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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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Surgical Gown, Level 3, grippers at neck, 4 sets of grippers on tie closure at waist, patented Size XL
Lac-Mac Limited
005XFAB-XL
In Commercial Distribution

  • 00627755055125 ()

  • Height: 56.25 Inch
  • Width: 27 Inch
005XFAB-XL

  • Surgical gown, reusable
Surgical Gown, Level 3, grippers at neck, 4 sets of grippers on tie closure at waist, patented Size L
Lac-Mac Limited
005XFAB-L
In Commercial Distribution

  • 00627755054128 ()

  • Height: 55.25 Inch
  • Width: 25 Inch
005XFAB-L

  • Surgical gown, reusable
Surgical Gown, Level 3, grippers at neck, 4 sets of grippers on tie closure at waist, patented Size M
Lac-Mac Limited
005XFAB-M
In Commercial Distribution

  • 00627755053121 ()

  • Height: 54.25 Inch
  • Width: 23 Inch
005XFAB-M

  • Surgical gown, reusable
Surgical Gown, Level 3, grippers at neck, 4 sets of grippers on tie closure at waist, patented Size S
Lac-Mac Limited
005XFAB-S
In Commercial Distribution

  • 00627755052124 ()

  • Height: 53.25 Inch
  • Width: 21 Inch
005XFAB-S

  • Surgical gown, reusable
Surgical Gown, Level 3, grippers at neck, 4 sets of grippers on tie closure at waist, patented Size XS
Lac-Mac Limited
005XFAB-XS
In Commercial Distribution

  • 00627755051127 ()

  • Height: 52.25 Inch
  • Width: 19 Inch
005XFAB-XS

  • Surgical gown, reusable
Stimulation Lead, 65 cm length, Assembled, tray packed, and sterilized at Oscor Caribe, then final packaged at Oscor, Inc.
MAINSTAY MEDICAL LIMITED
7M8165-006
Not in Commercial Distribution

  • 05391527772279 ()
8165

  • Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection
Senn Retractor 16cm Dbl. Ended 3 Sharp Prongs At One End & 6.0 X 13mm Blade At The Other End
ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATION
ASSI.MTK33316
In Commercial Distribution

  • 00841645133896 ()


  • Hand-held surgical retractor, reusable
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
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
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
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
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
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
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
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