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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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Semi kit: one blood glucose meter
EPS BIO TECHNOLOGY CORP.
EMMU
In Commercial Distribution

  • 00885017000065 ()
  • 01885017000064 ()
  • 10885017000062 ()


  • Glucose monitoring system IVD, home-use
3.5MM HEX HEAD SCREWDRIVER ONE PIECE
Smith & Nephew, Inc.
E0016721-1
In Commercial Distribution

  • 00885556768877 ()
E0016721-1

  • Surgical screwdriver, reusable
LHK, US,ONE LEGACY TISSUE SERV
MEDLINE INDUSTRIES, INC.
VASC1468
In Commercial Distribution

  • 40195327535965 ()
  • 10195327535964 ()
VASC1468

  • General surgical procedure kit, non-medicated, single-use
Inogen One G4 Oxygen Concentrator (10-06530-XX-XX)
Inogen, Inc.
630
In Commercial Distribution

  • 00817131020117 ()
IO-400

  • Mobile/portable oxygen concentrator
Inogen One G3 Oxygen Concentrator (10-06124-XX-XX)
Inogen, Inc.
1050
In Commercial Distribution

  • 00817131020063 ()
IO-300

  • Mobile/portable oxygen concentrator
Inogen One G3 Oxygen Concentrator (10-06124-XX-XX)
Inogen, Inc.
1050
In Commercial Distribution

  • 00817131020056 ()
IO-300

  • Mobile/portable oxygen concentrator
Inogen One G3 Oxygen Concentrator (10-03500-XX-XX)
Inogen, Inc.
840
In Commercial Distribution

  • 00817131020049 ()
IO-300

  • Mobile/portable oxygen concentrator
Inogen One G3 Oxygen Concentrator (10-03500-XX-XX)
Inogen, Inc.
840
In Commercial Distribution

  • 00817131020032 ()
IO-300

  • Mobile/portable oxygen concentrator
Inogen One G2 Oxygen Concentrator (10-04779-XX-XX)
Inogen, Inc.
1260
In Commercial Distribution

  • 00817131020025 ()
IO-200

  • Mobile/portable oxygen concentrator
Inogen One G2 Oxygen Concentrator (10-04779-XX-XX)
Inogen, Inc.
1260
In Commercial Distribution

  • 00817131020018 ()
IO-200

  • Mobile/portable oxygen concentrator
7 Panel One Step DOA Cup
BTNX Inc
D7.3-1V
In Commercial Distribution

  • 00722066004630 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
TAUT SYSTEM ONE TITANIUM4 WIRE BASKET
TELEFLEX INCORPORATED
IPN007724
In Commercial Distribution

  • 24026704418880 ()

  • Width: 15 Millimeter
  • Length: 100 Centimeter
50024

  • Laparoscopic access cannula, single-use
MOBILE ANEROID W ONE PIECE CUFF
WELCH ALLYN, INC.
901091
In Commercial Distribution

  • 00732094046755 ()
407637

  • Aneroid manual sphygmomanometer
RALLY ALL IN ONE CEMENT GUN
Smith & Nephew, Inc.
71271610
In Commercial Distribution

  • 00885556582275 ()
71271610

  • Orthopaedic cement/bone filler dispensing gun
One Piece™ Implant CA Driver
INTRA-LOCK INTERNATIONAL, INC.
OPCAD
In Commercial Distribution

  • D742OPCAD0 ()
OPCAD

  • Dental implant system
Aquilion ONE Pediatric Head Holder Pad
DOMICO MED-DEVICE, LLC
9094
In Commercial Distribution

  • 00810050242448 ()


  • Multifunction body cushion
  • Radiological headrest
PAD, AQUILION ONE CHILD HEAD HOLDER
DOMICO MED-DEVICE, LLC
9093
In Commercial Distribution

  • 00810050241397 ()


  • Multifunction body cushion
  • Radiological headrest
PAD, AQUILION ONE ADULT HEAD HOLDER
DOMICO MED-DEVICE, LLC
9092
In Commercial Distribution

  • 00810050241380 ()


  • Multifunction body cushion
  • Radiological headrest
VM 9 ONE COLOR KIT A2
Vita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft
BV9OCKA2V4
In Commercial Distribution

  • J017BV9OCKA2V40 ()
BV9OCKA2V4

  • Dental appliance fabrication material, ceramic
VM 9 One Color Kit 2M2
Vita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft
BV9OCK2M2V5
In Commercial Distribution

  • J017BV9OCK2M2V50 ()
BV9OCK2M2V5

  • Dental appliance fabrication material, ceramic
CPR faceshield with one way valve
B.L.S. Systems Limited
2030
In Commercial Distribution

  • B00220300 ()
  • B00220305 ()
2030

  • Cardiopulmonary resuscitation mask, single-use
One Step Custom Kit Micro-Introducer 6F
ARGON MEDICAL DEVICES, INC.
497864
Not in Commercial Distribution

  • 10886333215338 ()
  • 00886333215331 ()
  • 20886333215335 ()

  • 6F
497864

  • Vascular catheter introduction set, nonimplantable
9F One Piece/Tuohy-Borst Catheter Introducer
ARGON MEDICAL DEVICES, INC.
496136
In Commercial Distribution

  • 10886333213631 ()
  • 00886333213634 ()
  • 20886333213638 ()

  • 9F
496136

  • Vascular catheter introduction set, nonimplantable
8.5F One Piece/Tuohy-Borst Catheter Introducer
ARGON MEDICAL DEVICES, INC.
496135
In Commercial Distribution

  • 10886333213624 ()
  • 00886333213627 ()
  • 20886333213621 ()

  • 8.5F
496135

  • Vascular catheter introduction set, nonimplantable
8F One Piece/Tuohy-Borst Catheter Introducer
ARGON MEDICAL DEVICES, INC.
496134
In Commercial Distribution

  • 10886333213617 ()
  • 00886333213610 ()
  • 20886333213614 ()

  • 8F
496134

  • Vascular catheter introduction set, nonimplantable
6F One Piece/Tuohy-Borst Catheter Introducer
ARGON MEDICAL DEVICES, INC.
496132
In Commercial Distribution

  • 10886333213594 ()
  • 00886333213597 ()
  • 20886333213591 ()

  • 6F
496132

  • Vascular catheter introduction set, nonimplantable
One Step Micro Introducer System 4F
ARGON MEDICAL DEVICES, INC.
497821
Not in Commercial Distribution

  • 10886333222282 ()
  • 00886333222285 ()
  • 20886333222289 ()

  • 4F
497821

  • Vascular catheter introduction set, nonimplantable
ONE PIECE 9MM END CUTTING REAMER
Smith & Nephew, Inc.
E0015581-1
In Commercial Distribution

  • 00885556697276 ()
E0015581-1

  • Medullary canal orthopaedic reamer, rigid
ONE PIECE DESIGN C-ARM DRP, 1-EACH
Microtek Medical LLC
1
In Commercial Distribution

  • 30748426005513 ()
  • 00748426005512 ()
  • 50748426005517 ()


  • Instrument/equipment drape, single-use, sterile
All In One Stylet, Extra-Short, Sterile
SPINEOLOGY INC.
67-23-10-5
In Commercial Distribution

  • M7406700076 ()
670-0076

  • Orthopaedic intraoperative positioning pin, single-use
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