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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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Waist One Stump Panty Closed
Gottfried Medical, Inc.
335
In Commercial Distribution

  • G420335 ()
335

  • Compression/pressure shirt/pants
Waist One Stump Open Crotch
Gottfried Medical, Inc.
333
In Commercial Distribution

  • G420333 ()
333

  • Compression/pressure shirt/pants
Waist One Leg Panty Closed
Gottfried Medical, Inc.
303
In Commercial Distribution

  • G420303 ()
303

  • Compression/pressure shirt/pants
Waist One Leg Panty Open
Gottfried Medical, Inc.
302
In Commercial Distribution

  • G420302 ()
302

  • Compression/pressure shirt/pants
Waist One Leg Open Crotch
Gottfried Medical, Inc.
301
In Commercial Distribution

  • G420301 ()
301

  • Compression/pressure shirt/pants
Universal Handle, Cervical, One Sided
Ht Medical, LLC
B04-01
In Commercial Distribution

  • 00818345023758 ()


  • Surgical implant/trial-implant/sizer holder, reusable
Miko Mobility Base, One Size
Drive Devilbiss Healthcare
WCM-2000-2G
Not in Commercial Distribution

  • 00822383001517 ()


  • Attendant-only-propelled wheelchair, non-bariatric
ONE PATIENT KIT L112 SFP
LEONE SPA
F6120-91Z
In Commercial Distribution

  • 08033707100744 ()
F6120-91Z

  • Orthodontic bracket, metal
ONE PATIENT KIT L111 MBT
LEONE SPA
F4410-92Z
In Commercial Distribution

  • 08033707100737 ()
F4410-92Z

  • Orthodontic bracket, metal
ONE PATIENT KIT L139 ROTH
LEONE SPA
F4210-92Z
In Commercial Distribution

  • 08033707100720 ()
F4210-92Z

  • Orthodontic bracket, metal
ONE PATIENT KIT L197 ROTH
LEONE SPA
F4210-91Z
In Commercial Distribution

  • 08033707100713 ()
F4210-91Z

  • Orthodontic bracket, metal
ROCHARD RETR FRAME ONE SIDED
SKLAR CORPORATION
60-7435
In Commercial Distribution

  • 10649111454431 ()


  • Hand-held surgical retractor, reusable
MUST MC One Step Reducer
Medacta International SA
03.51.10.7420
In Commercial Distribution

  • 07630345733955 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
ONE Glowing Pleasures 36 ct
GLOBAL PROTECTION CORP.
11509
In Commercial Distribution

  • 80726893114803 ()
  • 00726893114807 ()


  • 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
ONE Legend Bowl of 100
GLOBAL PROTECTION CORP.
11400B
In Commercial Distribution

  • 80726893115206 ()
  • 00726893115200 ()


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

  • 80726893114698 ()
  • 00726893114692 ()


  • Basic male condom, Hevea-latex
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
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
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 PIECE™ IMPLANT ANALOG
INTRA-LOCK INTERNATIONAL, INC.
OPA2
In Commercial Distribution

  • D742OPA20 ()
OPA2

  • Dental implant system
ONE PIECE™ IMPLANT ANALOG
INTRA-LOCK INTERNATIONAL, INC.
OPA
In Commercial Distribution

  • D742OPA0 ()
OPA

  • Dental implant system
HOLDER, AQUILION ONE CARBON FIBER
DOMICO MED-DEVICE, LLC
9091
In Commercial Distribution

  • 00810050241212 ()


  • Multifunction body cushion
  • Radiological headrest
TOTAL HIP ONE AND TWO
MEDLINE INDUSTRIES, INC.
DYNJ910349C
In Commercial Distribution

  • 10198459131783 ()
DYNJ910349C

  • General surgical procedure kit, non-medicated, single-use
K000033 COMPOSIPRO ONE STEP KIT
Peter Brasseler Holdings, LLC
5008590U0
In Commercial Distribution

  • 00887919500292 ()


  • Diamond dental bur, single-use
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
One Step Micro-Introducer System 4F
ARGON MEDICAL DEVICES, INC.
497868
Not in Commercial Distribution

  • 10886333215376 ()
  • 00886333215379 ()
  • 20886333215373 ()

  • 4F
497868

  • Vascular catheter introduction set, nonimplantable
One Step Micro-Introducer System 7F
ARGON MEDICAL DEVICES, INC.
497867
Not in Commercial Distribution

  • 10886333215369 ()
  • 00886333215362 ()
  • 20886333215366 ()

  • 7F
497867

  • Vascular catheter introduction set, nonimplantable
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