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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24mm One Level Cervical Plate
Orthofix US LLC
62-6240
In Commercial Distribution

  • 18257200017942 ()

  • Length: 24 Millimeter


  • Spinal fixation plate, non-bioabsorbable
22mm One Level Cervical Plate
Orthofix US LLC
62-6220
In Commercial Distribution

  • 18257200017935 ()

  • Length: 22 Millimeter


  • Spinal fixation plate, non-bioabsorbable
20mm One Level Cervical Plate
Orthofix US LLC
62-6200
In Commercial Distribution

  • 18257200017928 ()

  • Length: 20 Millimeter


  • Spinal fixation plate, non-bioabsorbable
40589 One Step Face Protector
XODUS MEDICAL, INC.
40589
In Commercial Distribution

  • 20787551004773 ()
  • 00787551004779 ()
40589

  • Freestanding patient positioner, single-use
SINGLE-HAND ONE TUBE ANEROID BP-BLK-CL
RASHMAN CORPORATION
887-BLK
In Commercial Distribution

  • 00786511787448 ()


  • Aneroid manual sphygmomanometer
BLACK - ONE HAND ANEROID/BULK
RASHMAN CORPORATION
887-B-BLK
In Commercial Distribution

  • 00786511566210 ()


  • Aneroid manual sphygmomanometer
NAVY - ONE HAND ANEROID/BULK
RASHMAN CORPORATION
883-B-NAV
In Commercial Distribution

  • 00786511362539 ()


  • Aneroid manual sphygmomanometer
Glide Disposable Tip one pc.
ALMA LASERS LTD.
1
Not in Commercial Distribution

  • 17290110122192 ()
AARF15112101

  • Radio-frequency skin contouring system
BLACK - ONE HAND ANEROID/BULK
RASHMAN CORPORATION
883-B-BLK
In Commercial Distribution

  • 00786511076351 ()


  • Aneroid manual sphygmomanometer
NAVY - ONE HAND ANEROID/BULK
RASHMAN CORPORATION
887-B-NAV
In Commercial Distribution

  • 00786511076313 ()


  • Aneroid manual sphygmomanometer
UNO One piece implant analog
MIS Implants Technologies Ltd.
MO1-RSA10
Not in Commercial Distribution

  • 07290109010533 ()
MO1-RSA10

  • Dental implant suprastructure, temporary, preformed, single-use
TOTAL HIP ONE AND TWO
MEDLINE INDUSTRIES, INC.
DYNJ910349B
In Commercial Distribution

  • 10198459089008 ()
DYNJ910349B

  • General surgical procedure kit, non-medicated, single-use
Pad TTS Carbon one part
Baxter Medical Systems GmbH + Co. KG
1595434
Not in Commercial Distribution

  • 00887761969858 ()


  • Operating table mattress, basic
Leg section one part M
Baxter Medical Systems GmbH + Co. KG
2064464
Not in Commercial Distribution

  • 00887761967847 ()


  • Operating table orthopaedic extension, non-powered
MCLane One Step Pregnancy Cassette
SPD SWISS PRECISION DIAGNOSTICS GMBH
One Step Pregnancy Test
Not in Commercial Distribution

  • 10761706168490 ()
  • 00761706168493 ()
  • 20761706168497 ()


  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
DILATOR EX0318090 ONE STEP INNER
MEDTRONIC SOFAMOR DANEK, INC.
EX0318090
In Commercial Distribution

  • 00763000168704 ()


  • Spinal endoscopic-access system
DILATOR EX0318089 ONE STEP OUTER
MEDTRONIC SOFAMOR DANEK, INC.
EX0318089
In Commercial Distribution

  • 00763000168698 ()


  • Spinal endoscopic-access system
TAUT SYSTEM ONE GUIDEWIRE 0.035
TELEFLEX INCORPORATED
IPN007729
In Commercial Distribution

  • 24026704418897 ()

  • Length: 10 Inch
50035

  • Laparoscopic access cannula, single-use
CGT BROACH PROXIMAL ONE SIZE
Smith & Nephew, Inc.
CGT-PST
In Commercial Distribution

  • 00885556834350 ()
CGT-PST

  • Orthopaedic broach
CGT BROACH DISTAL ONE SIZE
Smith & Nephew, Inc.
CGT-DST
In Commercial Distribution

  • 00885556834336 ()
CGT-DST

  • Orthopaedic broach
ENA-BOND ONE COMPONENT BONDING 2ml
MICERIUM SPA
COSM300A2
In Commercial Distribution

  • EMICCOSM300A20 ()

  • Total Volume: 2 Milliliter
COSM300A2

  • Dentine bonding agent/set
ENA-BOND ONE COMPONENT BONDING 5ml
MICERIUM SPA
COSM300A
In Commercial Distribution

  • EMICCOSM300A1 ()
  • EMICCOSM300A0 ()

  • Total Volume: 5 Milliliter
COSM300A

  • Dentine bonding agent/set
All In One Stylet, Short
SPINEOLOGY INC.
67-23-10-4
In Commercial Distribution

  • M7406700075 ()
670-0075

  • Surgical drill guide, single-use
All In One Stylet, Long
SPINEOLOGY INC.
67-23-10-3
In Commercial Distribution

  • M7406700074 ()
670-0074

  • Surgical drill guide, single-use
4F ONE- STEP INTRODUCER KIT
STRADIS MEDICAL, LLC
525-029
Not in Commercial Distribution

  • M752525029R11 ()

  • Length: 45 Centimeter
  • Catheter Gauge: 4 French


  • Vascular catheter introduction set, nonimplantable
One Thing Silver (Polarized) Spectacle
Kenmark Optical, Inc.
OTHGSI52
In Commercial Distribution

  • 00715317176217 ()


  • Tinted non-prescription spectacles
One Thing Gold (Polarized) Spectacle
Kenmark Optical, Inc.
OTHGYG52
In Commercial Distribution

  • 00715317176170 ()


  • Tinted non-prescription spectacles
TOTAL HIP ONE AND TWO
MEDLINE INDUSTRIES, INC.
DYNJ910349A
In Commercial Distribution

  • 10195327670054 ()
DYNJ910349A

  • General surgical procedure kit, non-medicated, single-use
TOTAL HIP ONE AND TWO
MEDLINE INDUSTRIES, INC.
DYNJ910349
In Commercial Distribution

  • 10195327632168 ()
DYNJ910349

  • General surgical procedure kit, non-medicated, single-use
ONE PIECE FLEXIBLE REAMER - 13MM
Smith & Nephew, Inc.
E0016132-2
In Commercial Distribution

  • 00885556725146 ()
E0016132-2

  • Bone-resection orthopaedic reamer, reusable
ONE PIECE FLEXIBLE REAMER - 11.5MM
Smith & Nephew, Inc.
E0016132-1
In Commercial Distribution

  • 00885556725139 ()
E0016132-1

  • Bone-resection orthopaedic reamer, reusable
REDAPT ONE PIECE STEM EXTRACTOR
Smith & Nephew, Inc.
E0017210-1
In Commercial Distribution

  • 00885556801666 ()
E0017210-1

  • Orthopaedic implant-instrument extension adaptor, reusable
ONE PIECE FLEXIBLE REAMER - 14.5MM
Smith & Nephew, Inc.
E0016000-12
In Commercial Distribution

  • 00885556718681 ()
E0016000-12

  • Bone-resection orthopaedic reamer, reusable
ONE PIECE FLEXIBLE REAMER - 14MM
Smith & Nephew, Inc.
E0016000-11
In Commercial Distribution

  • 00885556718674 ()
E0016000-11

  • Bone-resection orthopaedic reamer, reusable
ONE PIECE FLEXIBLE REAMER - 13.5MM
Smith & Nephew, Inc.
E0016000-10
In Commercial Distribution

  • 00885556718667 ()
E0016000-10

  • Bone-resection orthopaedic reamer, reusable
ONE PIECE FLEXIBLE REAMER - 13MM
Smith & Nephew, Inc.
E0016000-9
In Commercial Distribution

  • 00885556718650 ()
E0016000-9

  • Bone-resection orthopaedic reamer, reusable
ONE PIECE FLEXIBLE REAMER - 12.5MM
Smith & Nephew, Inc.
E0016000-8
In Commercial Distribution

  • 00885556718643 ()
E0016000-8

  • Bone-resection orthopaedic reamer, reusable
ONE PIECE FLEXIBLE REAMER - 12MM
Smith & Nephew, Inc.
E0016000-7
In Commercial Distribution

  • 00885556718636 ()
E0016000-7

  • Bone-resection orthopaedic reamer, reusable
ONE PIECE FLEXIBLE REAMER - 11.5MM
Smith & Nephew, Inc.
E0016000-6
In Commercial Distribution

  • 00885556718629 ()
E0016000-6

  • Bone-resection orthopaedic reamer, reusable
ONE PIECE FLEXIBLE REAMER - 11MM
Smith & Nephew, Inc.
E0016000-5
In Commercial Distribution

  • 00885556718612 ()
E0016000-5

  • Bone-resection orthopaedic reamer, reusable
ONE PIECE FLEXIBLE REAMER - 10.5MM
Smith & Nephew, Inc.
E0016000-4
In Commercial Distribution

  • 00885556718605 ()
E0016000-4

  • Bone-resection orthopaedic reamer, reusable
ONE PIECE FLEXIBLE REAMER - 10MM
Smith & Nephew, Inc.
E0016000-3
In Commercial Distribution

  • 00885556718599 ()
E0016000-3

  • Bone-resection orthopaedic reamer, reusable
ONE PIECE FLEXIBLE REAMER - 9.5MM
Smith & Nephew, Inc.
E0016000-2
In Commercial Distribution

  • 00885556718582 ()
E0016000-2

  • Bone-resection orthopaedic reamer, reusable
ONE PIECE FLEXIBLE REAMER - 9MM
Smith & Nephew, Inc.
E0016000-1
In Commercial Distribution

  • 00885556718575 ()
E0016000-1

  • Bone-resection orthopaedic reamer, reusable
kit only has one meter
BIONIME CORPORATION
GM291
In Commercial Distribution

  • 00883489002525 ()
  • 00883489002518 ()
  • 10883489002522 ()
  • 20883489002529 ()


  • Glucose monitoring system IVD, home-use
STR VITRECTOMY, VISION ONE PK
Cardinal Health 200, LLC
MEY36VTVOA
In Commercial Distribution

  • 50885425211614 ()
  • 00885425211619 ()
MEY36VTVOA

  • Ophthalmic surgical procedure kit, non-medicated, single-use
ONE Legend Bowl of 100
GLOBAL PROTECTION CORP.
11400B
In Commercial Distribution

  • 80726893115206 ()
  • 00726893115200 ()


  • Basic male condom, Hevea-latex
ONE Glowing Pleasures 36 ct
GLOBAL PROTECTION CORP.
11509
In Commercial Distribution

  • 80726893114803 ()
  • 00726893114807 ()


  • Basic male condom, Hevea-latex
ONE SUPER STUDS 36 CT
GLOBAL PROTECTION CORP.
111709
In Commercial Distribution

  • 80726893114698 ()
  • 00726893114692 ()


  • Basic male condom, Hevea-latex
ONE Mixed Pleasures 12 pack
GLOBAL PROTECTION CORP.
11012
In Commercial Distribution

  • 10726893112015 ()
  • 00726893112018 ()
  • 20726893112012 ()
  • 80726893112014 ()


  • Basic male condom, Hevea-latex
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