Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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SC AT PELHAM D AND C GYN PACK
Cardinal Health 200, LLC
SMA23DPPLB
In Commercial Distribution

  • 50195594373793 ()
  • 10195594373795 ()
SMA23DPPLB

  • Obstetrical/gynaecological surgical procedure kit, medicated
SC AT PELHAM D AND C GYN PACK
Cardinal Health 200, LLC
SMA23DPPLA
In Commercial Distribution

  • 50195594187987 ()
  • 10195594187989 ()
SMA23DPPLA

  • Obstetrical/gynaecological surgical procedure kit, medicated
Stimulation Lead, 45 cm length, Assembled and tray packed at Oscor Caribe, then sterilized and final packaged at Oscor, Inc.
MAINSTAY MEDICAL LIMITED
7M8145-005
In Commercial Distribution

  • 05391527772064 ()
8145

  • Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection
Urine based drug of abuse test for THC
PHAMATECH, INCORPORATED
9078T
In Commercial Distribution

  • 00674033090781 ()


  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
Single Panel Cocaine urine drug test device with Timer
PHAMATECH, INCORPORATED
9073T
In Commercial Distribution

  • 00674033090736 ()


  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
Urine based drug testing device for Methamphetamine
PHAMATECH, INCORPORATED
9068T
In Commercial Distribution

  • 00674033090682 ()


  • Amphetamine-specific IVD, kit, rapid ICT, clinical
A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb upon which it is fitted (typically a leg, but some types may be used on an arm), primarily to improve venous return to treat/prevent one or more disorders of circulation(e.g. oedema, deep vein thrombosis (DVT), varicosis). It might be referred to as a compression stocking or flight sock and may be intended to apply a graduated pressure across a limb,however it is not intended to support an injured joint. It is normally available (non-prescription) over-the-counter (OTC) for home-use and/or for hospitalized or institutionalized patients. This is a reusable device.
SIGVARIS INC
355509
In Commercial Distribution

  • 07613378277368 ()

  • Pressure, 18-21 mmHg
355509

  • Compression/pressure sock/stocking, single-use
A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb upon which it is fitted (typically a leg, but some types may be used on an arm), primarily to improve venous return to treat/prevent one or more disorders of circulation(e.g. oedema, deep vein thrombosis (DVT), varicosis). It might be referred to as a compression stocking or flight sock and may be intended to apply a graduated pressure across a limb,however it is not intended to support an injured joint. It is normally available (non-prescription) over-the-counter (OTC) for home-use and/or for hospitalized or institutionalized patients. This is a reusable device.
SIGVARIS INC
320236
In Commercial Distribution

  • 07613378199820 ()

  • Pressure, 18-21 mmHg
320236

  • Compression/pressure sock/stocking, single-use
A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb upon which it is fitted (typically a leg, but some types may be used on an arm), primarily to improve venous return to treat/prevent one or more disorders of circulation(e.g. oedema, deep vein thrombosis (DVT), varicosis). It might be referred to as a compression stocking or flight sock and may be intended to apply a graduated pressure across a limb,however it is not intended to support an injured joint. It is normally available (non-prescription) over-the-counter (OTC) for home-use and/or for hospitalized or institutionalized patients. This is a reusable device.
SIGVARIS INC
320271
In Commercial Distribution

  • 07613378199479 ()

  • Pressure, 18-21 mmHg
320271

  • Compression/pressure sock/stocking, single-use
A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb upon which it is fitted (typically a leg, but some types may be used on an arm), primarily to improve venous return to treat/prevent one or more disorders of circulation(e.g. oedema, deep vein thrombosis (DVT), varicosis). It might be referred to as a compression stocking or flight sock and may be intended to apply a graduated pressure across a limb,however it is not intended to support an injured joint. It is normally available (non-prescription) over-the-counter (OTC) for home-use and/or for hospitalized or institutionalized patients. This is a reusable device.
SIGVARIS INC
320272
In Commercial Distribution

  • 07613378199462 ()

  • Pressure, 18-21 mmHg
320272

  • Compression/pressure sock/stocking, single-use
A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb upon which it is fitted (typically a leg, but some types may be used on an arm), primarily to improve venous return to treat/prevent one or more disorders of circulation(e.g. oedema, deep vein thrombosis (DVT), varicosis). It might be referred to as a compression stocking or flight sock and may be intended to apply a graduated pressure across a limb,however it is not intended to support an injured joint. It is normally available (non-prescription) over-the-counter (OTC) for home-use and/or for hospitalized or institutionalized patients. This is a reusable device.
SIGVARIS INC
320313
In Commercial Distribution

  • 07613378199059 ()

  • Pressure, 18-21 mmHg
320313

  • Compression/pressure sock/stocking, single-use
A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb upon which it is fitted (typically a leg, but some types may be used on an arm), primarily to improve venous return to treat/prevent one or more disorders of circulation(e.g. oedema, deep vein thrombosis (DVT), varicosis). It might be referred to as a compression stocking or flight sock and may be intended to apply a graduated pressure across a limb,however it is not intended to support an injured joint. It is normally available (non-prescription) over-the-counter (OTC) for home-use and/or for hospitalized or institutionalized patients. This is a reusable device.
SIGVARIS INC
320349
In Commercial Distribution

  • 07613378198694 ()

  • Pressure, 18-21 mmHg
320349

  • Compression/pressure sock/stocking, single-use
A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb upon which it is fitted (typically a leg, but some types may be used on an arm), primarily to improve venous return to treat/prevent one or more disorders of circulation(e.g. oedema, deep vein thrombosis (DVT), varicosis). It might be referred to as a compression stocking or flight sock and may be intended to apply a graduated pressure across a limb,however it is not intended to support an injured joint. It is normally available (non-prescription) over-the-counter (OTC) for home-use and/or for hospitalized or institutionalized patients. This is a reusable device.
SIGVARIS INC
320391
In Commercial Distribution

  • 07613378198274 ()

  • Pressure, 18-21 mmHg
320391

  • Compression/pressure sock/stocking, single-use
A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb upon which it is fitted (typically a leg, but some types may be used on an arm), primarily to improve venous return to treat/prevent one or more disorders of circulation(e.g. oedema, deep vein thrombosis (DVT), varicosis). It might be referred to as a compression stocking or flight sock and may be intended to apply a graduated pressure across a limb,however it is not intended to support an injured joint. It is normally available (non-prescription) over-the-counter (OTC) for home-use and/or for hospitalized or institutionalized patients. This is a reusable device.
SIGVARIS INC
320392
In Commercial Distribution

  • 07613378198267 ()

  • Pressure, 18-21 mmHg
320392

  • Compression/pressure sock/stocking, single-use
A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb upon which it is fitted (typically a leg, but some types may be used on an arm), primarily to improve venous return to treat/prevent one or more disorders of circulation(e.g. oedema, deep vein thrombosis (DVT), varicosis). It might be referred to as a compression stocking or flight sock and may be intended to apply a graduated pressure across a limb,however it is not intended to support an injured joint. It is normally available (non-prescription) over-the-counter (OTC) for home-use and/or for hospitalized or institutionalized patients. This is a reusable device.
SIGVARIS INC
320427
In Commercial Distribution

  • 07613378197918 ()

  • Pressure, 18-21 mmHg
320427

  • Compression/pressure sock/stocking, single-use
A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb upon which it is fitted (typically a leg, but some types may be used on an arm), primarily to improve venous return to treat/prevent one or more disorders of circulation(e.g. oedema, deep vein thrombosis (DVT), varicosis). It might be referred to as a compression stocking or flight sock and may be intended to apply a graduated pressure across a limb,however it is not intended to support an injured joint. It is normally available (non-prescription) over-the-counter (OTC) for home-use and/or for hospitalized or institutionalized patients. This is a reusable device.
SIGVARIS INC
320428
In Commercial Distribution

  • 07613378197901 ()

  • Pressure, 18-21 mmHg
320428

  • Compression/pressure sock/stocking, single-use
A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb upon which it is fitted (typically a leg, but some types may be used on an arm), primarily to improve venous return to treat/prevent one or more disorders of circulation(e.g. oedema, deep vein thrombosis (DVT), varicosis). It might be referred to as a compression stocking or flight sock and may be intended to apply a graduated pressure across a limb,however it is not intended to support an injured joint. It is normally available (non-prescription) over-the-counter (OTC) for home-use and/or for hospitalized or institutionalized patients. This is a reusable device.
SIGVARIS INC
320469
In Commercial Distribution

  • 07613378197499 ()

  • Pressure, 18-21 mmHg
320469

  • Compression/pressure sock/stocking, single-use
A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb upon which it is fitted (typically a leg, but some types may be used on an arm), primarily to improve venous return to treat/prevent one or more disorders of circulation(e.g. oedema, deep vein thrombosis (DVT), varicosis). It might be referred to as a compression stocking or flight sock and may be intended to apply a graduated pressure across a limb,however it is not intended to support an injured joint. It is normally available (non-prescription) over-the-counter (OTC) for home-use and/or for hospitalized or institutionalized patients. This is a reusable device.
SIGVARIS INC
320470
In Commercial Distribution

  • 07613378197482 ()

  • Pressure, 18-21 mmHg
320470

  • Compression/pressure sock/stocking, single-use
A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb upon which it is fitted (typically a leg, but some types may be used on an arm), primarily to improve venous return to treat/prevent one or more disorders of circulation(e.g. oedema, deep vein thrombosis (DVT), varicosis). It might be referred to as a compression stocking or flight sock and may be intended to apply a graduated pressure across a limb,however it is not intended to support an injured joint. It is normally available (non-prescription) over-the-counter (OTC) for home-use and/or for hospitalized or institutionalized patients. This is a reusable device.
SIGVARIS INC
320505
In Commercial Distribution

  • 07613378197130 ()

  • Pressure, 18-21 mmHg
320505

  • Compression/pressure sock/stocking, single-use
A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb upon which it is fitted (typically a leg, but some types may be used on an arm), primarily to improve venous return to treat/prevent one or more disorders of circulation(e.g. oedema, deep vein thrombosis (DVT), varicosis). It might be referred to as a compression stocking or flight sock and may be intended to apply a graduated pressure across a limb,however it is not intended to support an injured joint. It is normally available (non-prescription) over-the-counter (OTC) for home-use and/or for hospitalized or institutionalized patients. This is a reusable device.
SIGVARIS INC
320548
In Commercial Distribution

  • 07613378196706 ()

  • Pressure, 18-21 mmHg
320548

  • Compression/pressure sock/stocking, single-use
A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb upon which it is fitted (typically a leg, but some types may be used on an arm), primarily to improve venous return to treat/prevent one or more disorders of circulation(e.g. oedema, deep vein thrombosis (DVT), varicosis). It might be referred to as a compression stocking or flight sock and may be intended to apply a graduated pressure across a limb,however it is not intended to support an injured joint. It is normally available (non-prescription) over-the-counter (OTC) for home-use and/or for hospitalized or institutionalized patients. This is a reusable device.
SIGVARIS INC
320583
In Commercial Distribution

  • 07613378196355 ()

  • Pressure, 18-21 mmHg
320583

  • Compression/pressure sock/stocking, single-use
A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb upon which it is fitted (typically a leg, but some types may be used on an arm), primarily to improve venous return to treat/prevent one or more disorders of circulation(e.g. oedema, deep vein thrombosis (DVT), varicosis). It might be referred to as a compression stocking or flight sock and may be intended to apply a graduated pressure across a limb,however it is not intended to support an injured joint. It is normally available (non-prescription) over-the-counter (OTC) for home-use and/or for hospitalized or institutionalized patients. This is a reusable device.
SIGVARIS INC
320584
In Commercial Distribution

  • 07613378196348 ()

  • Pressure, 18-21 mmHg
320584

  • Compression/pressure sock/stocking, single-use
A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb upon which it is fitted (typically a leg, but some types may be used on an arm), primarily to improve venous return to treat/prevent one or more disorders of circulation(e.g. oedema, deep vein thrombosis (DVT), varicosis). It might be referred to as a compression stocking or flight sock and may be intended to apply a graduated pressure across a limb,however it is not intended to support an injured joint. It is normally available (non-prescription) over-the-counter (OTC) for home-use and/or for hospitalized or institutionalized patients. This is a reusable device.
SIGVARIS INC
355545
In Commercial Distribution

  • 07613378277726 ()

  • Pressure, 18-21 mmHg
355545

  • Compression/pressure sock/stocking, single-use
A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb upon which it is fitted (typically a leg, but some types may be used on an arm), primarily to improve venous return to treat/prevent one or more disorders of circulation(e.g. oedema, deep vein thrombosis (DVT), varicosis). It might be referred to as a compression stocking or flight sock and may be intended to apply a graduated pressure across a limb,however it is not intended to support an injured joint. It is normally available (non-prescription) over-the-counter (OTC) for home-use and/or for hospitalized or institutionalized patients. This is a reusable device.
SIGVARIS INC
355544
In Commercial Distribution

  • 07613378277719 ()

  • Pressure, 18-21 mmHg
355544

  • Compression/pressure sock/stocking, single-use
A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb upon which it is fitted (typically a leg, but some types may be used on an arm), primarily to improve venous return to treat/prevent one or more disorders of circulation(e.g. oedema, deep vein thrombosis (DVT), varicosis). It might be referred to as a compression stocking or flight sock and may be intended to apply a graduated pressure across a limb,however it is not intended to support an injured joint. It is normally available (non-prescription) over-the-counter (OTC) for home-use and/or for hospitalized or institutionalized patients. This is a reusable device.
SIGVARIS INC
355508
In Commercial Distribution

  • 07613378277351 ()

  • Pressure, 18-21 mmHg
355508

  • Compression/pressure sock/stocking, single-use
A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb upon which it is fitted (typically a leg, but some types may be used on an arm), primarily to improve venous return to treat/prevent one or more disorders of circulation(e.g. oedema, deep vein thrombosis (DVT), varicosis). It might be referred to as a compression stocking or flight sock and may be intended to apply a graduated pressure across a limb,however it is not intended to support an injured joint. It is normally available (non-prescription) over-the-counter (OTC) for home-use and/or for hospitalized or institutionalized patients. This is a reusable device.
SIGVARIS INC
320235
In Commercial Distribution

  • 07613378199837 ()

  • Pressure, 18-21 mmHg
320235

  • Compression/pressure sock/stocking, single-use
A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb upon which it is fitted (typically a leg, but some types may be used on an arm), primarily to improve venous return to treat/prevent one or more disorders of circulation(e.g. oedema, deep vein thrombosis (DVT), varicosis). It might be referred to as a compression stocking or flight sock and may be intended to apply a graduated pressure across a limb,however it is not intended to support an injured joint. It is normally available (non-prescription) over-the-counter (OTC) for home-use and/or for hospitalized or institutionalized patients. This is a reusable device.
SIGVARIS INC
320314
In Commercial Distribution

  • 07613378199042 ()

  • Pressure, 18-21 mmHg
320314

  • Compression/pressure sock/stocking, single-use
A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb upon which it is fitted (typically a leg, but some types may be used on an arm), primarily to improve venous return to treat/prevent one or more disorders of circulation(e.g. oedema, deep vein thrombosis (DVT), varicosis). It might be referred to as a compression stocking or flight sock and may be intended to apply a graduated pressure across a limb,however it is not intended to support an injured joint. It is normally available (non-prescription) over-the-counter (OTC) for home-use and/or for hospitalized or institutionalized patients. This is a reusable device.
SIGVARIS INC
320350
In Commercial Distribution

  • 07613378198687 ()

  • Pressure, 18-21 mmHg
320350

  • Compression/pressure sock/stocking, single-use
A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb upon which it is fitted (typically a leg, but some types may be used on an arm), primarily to improve venous return to treat/prevent one or more disorders of circulation(e.g. oedema, deep vein thrombosis (DVT), varicosis). It might be referred to as a compression stocking or flight sock and may be intended to apply a graduated pressure across a limb,however it is not intended to support an injured joint. It is normally available (non-prescription) over-the-counter (OTC) for home-use and/or for hospitalized or institutionalized patients. This is a reusable device.
SIGVARIS INC
320506
In Commercial Distribution

  • 07613378197123 ()

  • Pressure, 18-21 mmHg
320506

  • Compression/pressure sock/stocking, single-use
A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb upon which it is fitted (typically a leg, but some types may be used on an arm), primarily to improve venous return to treat/prevent one or more disorders of circulation(e.g. oedema, deep vein thrombosis (DVT), varicosis). It might be referred to as a compression stocking or flight sock and may be intended to apply a graduated pressure across a limb,however it is not intended to support an injured joint. It is normally available (non-prescription) over-the-counter (OTC) for home-use and/or for hospitalized or institutionalized patients. This is a reusable device.
SIGVARIS INC
320547
In Commercial Distribution

  • 07613378196713 ()

  • Pressure, 18-21 mmHg
320547

  • Compression/pressure sock/stocking, single-use
Zeiss Microscope Eye Protection Filter
AMERICAN MEDICAL SYSTEMS
0010-0041
In Commercial Distribution

  • 00878953000237 ()

  • Optical Density 5 at 532nm and 1064nm


  • Operator eye protection laser filter
A Safedraw Septum connected to a 5cc Restricted Syringe stops at 2cc via a 60” Pressure Tubing. It has a 12” Pressure tubing on the patient side and a colour set.
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
682145
In Commercial Distribution

  • 50886333621458 ()
  • 00886333621453 ()

  • septum with 5cc syringe stops at 2cc
682145

  • Arterial blood sampling kit
Wild Microscope Eye Protection Filter
AMERICAN MEDICAL SYSTEMS
0010-0047
Not in Commercial Distribution

  • 00878953000268 ()

  • Optical Density 5 at 532nm and 1064nm


  • Operator eye protection laser filter
Storz Microscope Eye Protection Filter
AMERICAN MEDICAL SYSTEMS
0010-0046
Not in Commercial Distribution

  • 00878953000251 ()

  • Optical Density 5 at 532nm and 1064nm


  • Operator eye protection laser filter
Zeiss Microscope Eye Protection Filter
AMERICAN MEDICAL SYSTEMS
0010-0045
Not in Commercial Distribution

  • 00878953000244 ()

  • Optical Density 5 at 532nm and 1064nm


  • Operator eye protection laser filter
Austin strut caliper and measuring gauge, 6 1/4'', straight shaft, prongs at 3.5mm and 4.5mm, groove at 4.0mm, round handle
AMBLER SURGICAL CORP.
Austin strut caliper and measuring gauge
In Commercial Distribution

  • 00190660001650 ()
14-100

  • Fistula probe
Mammography Gown, Front Lapover, inside & outside ties at front waist, 3/4 length sleeves, single metal snap at front opening, 3XL
STANDARD TEXTILE CO., INC.
74347789
Not in Commercial Distribution

  • 00634916457667 ()
  • 10634916457667 ()
74347789

  • Patient gown, reusable
Mammography Gown, Front Lapover, inside & outside ties at front waist, 3/4 length sleeves, single metal snap at front opening, OSFA
STANDARD TEXTILE CO., INC.
74347089
Not in Commercial Distribution

  • 00634916457643 ()
  • 10634916457643 ()
74347089

  • Patient gown, reusable
Surgical Gown, Level 4, custom color code, full barrier front, grips at neck, ties at waist, customer barcode, patented Size XL
Lac-Mac Limited
005XP-XL
In Commercial Distribution

  • 00627755055163 ()

  • Height: 53 Inch
  • Width: 29 Inch
005XP-XL

  • Surgical gown, reusable
Surgical Gown, Level 4, custom color code, full barrier front, grips at neck, ties at waist, customer barcode, patented Size L
Lac-Mac Limited
005XP-L
In Commercial Distribution

  • 00627755054166 ()

  • Height: 52.5 Inch
  • Width: 27 Inch
005XP-L

  • Surgical gown, reusable
INPR, ITE VC AT WL L BE INO PRO
Oticon A/S
109026
In Commercial Distribution

  • 05707131198570 ()


  • Air-conduction hearing aid, in-the-ear
INPR, ITE VC AT WL R BE INO PRO
Oticon A/S
109025
In Commercial Distribution

  • 05707131198563 ()


  • Air-conduction hearing aid, in-the-ear
INPR, ITC/ITE AT WL L BE INO PRO
Oticon A/S
109022
In Commercial Distribution

  • 05707131198532 ()


  • Air-conduction hearing aid, in-the-ear
INPR, ITC/ITE AT WL R BE INO PRO
Oticon A/S
109021
In Commercial Distribution

  • 05707131198525 ()


  • Air-conduction hearing aid, in-the-ear
ACPR, ITE VC AT WL L BE ACTO PRO
Oticon A/S
100789
In Commercial Distribution

  • 05707131165275 ()


  • Air-conduction hearing aid, in-the-ear
ACPR, ITE VC AT WL R BE ACTO PRO
Oticon A/S
100788
In Commercial Distribution

  • 05707131165268 ()


  • Air-conduction hearing aid, in-the-ear
ACPR, ITC/ITE AT WL L BE ACTO PRO
Oticon A/S
100785
In Commercial Distribution

  • 05707131165237 ()


  • Air-conduction hearing aid, in-the-ear
ACPR, ITC/ITE AT WL R BE ACTO PRO
Oticon A/S
100784
In Commercial Distribution

  • 05707131165220 ()


  • Air-conduction hearing aid, in-the-ear
AGPR, ITE VC WL AT L BE AGIL PRO
Oticon A/S
106-23-270-10
In Commercial Distribution

  • 05707131151834 ()


  • Air-conduction hearing aid, in-the-ear
AGPR, ITE VC WL AT R BE AGIL PRO
Oticon A/S
106-23-260-10
In Commercial Distribution

  • 05707131151827 ()


  • Air-conduction hearing aid, in-the-ear
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