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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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MDT Diamond Coated Dental Flexible Strips - 07291046700839

SERRATED SAW One Sided w/6.0mm
M.D.T. - MICRO DIAMOND TECHNOLOGIES LTD.
SBS-000-N5
In Commercial Distribution

  • 07291046700839 ()
SBS-000

  • Dental abrasive strip, reusable

MDT Diamond Coated Dental Flexible Strips - 07291046700624

SERRATED SAW One Sided w/6.0mm
M.D.T. - MICRO DIAMOND TECHNOLOGIES LTD.
SBS-000-N1
In Commercial Distribution

  • 07291046700624 ()
SBS-000

  • Dental abrasive strip, reusable

MDT Diamond Coated Dental Flexible Strips - 07291046700204

SERRATED SAW One Sided w/6.0mm
M.D.T. - MICRO DIAMOND TECHNOLOGIES LTD.
SBS-000-M1
In Commercial Distribution

  • 07291046700204 ()
SBS-000

  • Dental abrasive strip, reusable

Mepitel® One - 07332551023768

Mepitel One 10x18 cm, FR ph
Mölnlycke Health Care AB
289500
In Commercial Distribution

  • 07323190232451 ()
  • 07332551023768 ()
  • 07323190232444 ()

  • 10cm x 18cm


  • Wound-nonadherent dressing, permeable, non-antimicrobial

Mepitel® One - 07332551023744

Mepitel One 7,5x10 cm, FR ph
Mölnlycke Health Care AB
289300
In Commercial Distribution

  • 07323190232253 ()
  • 07323190232260 ()
  • 07332551023744 ()

  • 7.5cm x 10cm


  • Wound-nonadherent dressing, permeable, non-antimicrobial

Mepitel® One - 07332551023720

Mepitel One 5x7,5 cm, FR ph
Mölnlycke Health Care AB
289100
In Commercial Distribution

  • 07323190232161 ()
  • 07332551023720 ()
  • 07323190232154 ()

  • 5cm x 7.5cm


  • Wound-nonadherent dressing, permeable, non-antimicrobial

Compressible Limb Therapy System(LX7(V7)) - 38809315677982

4Chamber Center-body extension zipper (one size)
DAESUNG MAREF CO.,LTD.
ACg0433
Not in Commercial Distribution

  • 38809315677982 ()
  • 08809315677974 ()


  • Pneumatic massager

Arm-Positioning - 00887761973404

Arm support device one hand operation
Baxter Medical Systems GmbH + Co. KG
4549528
In Commercial Distribution

  • 00887761973404 ()


  • Operating table orthopaedic extension, non-powered

N/A - 00810050241380

PAD, AQUILION ONE ADULT HEAD HOLDER
DOMICO MED-DEVICE, LLC
9092
In Commercial Distribution

  • 00810050241380 ()


  • Multifunction body cushion
  • Radiological headrest

NA - 00810050242448

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

  • 00810050242448 ()


  • Multifunction body cushion
  • Radiological headrest

NA - 00810050241397

PAD, AQUILION ONE CHILD HEAD HOLDER
DOMICO MED-DEVICE, LLC
9093
In Commercial Distribution

  • 00810050241397 ()


  • Multifunction body cushion
  • Radiological headrest

ONE Extra Strong - 20726893115464

ONE Extra Strong NYC Bulk case
GLOBAL PROTECTION CORP.
112400C-NYC
In Commercial Distribution

  • 80726893115466 ()
  • 20726893115464 ()


  • Basic male condom, Hevea-latex

ONE Vanish condoms - 20726893111886

ONE Vanish Bulk Case of 1000
GLOBAL PROTECTION CORP.
111300C
In Commercial Distribution

  • 80726893111888 ()
  • 20726893111886 ()


  • Basic male condom, Hevea-latex

Hahnenkratt - E206200

Nyström, one pair, I and II
E. Hahnenkratt GmbH
20
In Commercial Distribution

  • E206200 ()


  • Dental matrix band tensioner

MissLan - 06974464590084

One Step HCG Urine Test Midstream
Guangzhou Decheng Biotechnology Co., LTD
0741M4X003
Not in Commercial Distribution

  • 06974464590084 ()


  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical

Hoopla Retractor - 00810032660451

Hoopla Retractor, One Size, 10-Pack, EDU
ZYRIS, INC.
CIR0101
In Commercial Distribution

  • 10810032660458 ()
  • 00810032660451 ()
CIR0101

  • Hand-held dental retractor

DeRoyal - 00749756664752

Hp One Way Stopcock W/Ra500C
DEROYAL INDUSTRIES, INC.
35-400756
In Commercial Distribution

  • 50749756664757 ()
  • 00749756664752 ()


  • Angiography kit

CDI™ Blood Parameter Monitoring System 500 - 00886799001615

Monitor with one blood parameter module.
Terumo Cardiovascular Systems Corporation
500A
In Commercial Distribution

  • 00886799001615 ()
500A

  • Extracorporeal blood gas/pH monitor

One Step Micro Introducer System - 00886333222285

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 Step Custom Kit Micro-Introducer - 00886333215331

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

One Piece/Tuohy-Borst Catheter Introducer - 00886333213597

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 Piece/Tuohy-Borst Catheter Introducer - 00886333213634

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

One Piece/Tuohy-Borst Catheter Introducer - 00886333213627

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

One Piece/Tuohy-Borst Catheter Introducer - 00886333213610

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

BioPro - M20922862

ONE PIECE THUMB STEM RASP 10.0MM
BIOPRO, INC.
22862
In Commercial Distribution

  • M20922862 ()


  • Surgical implant/trial-implant/sizer holder, reusable

Pedicraft - 00766923347218

Crib Bed 35x76 One Drop Side
PEDICRAFT, INC.
34721
In Commercial Distribution

  • 00766923347218 ()
34721

  • Paediatric bed

BVI - 16931918198453

Surgical Gown_Non-Reinforced_W/ one hand towle_XXL_Non-Sterile_28ea/cs
GRI Medical & Electronic Technology Co., Ltd.
60300457
In Commercial Distribution

  • 06931918198456 ()
  • 16931918198453 ()


  • Surgical gown, single-use

Alleset - 16931918196435

Surgical Gown_Non-Reinforced_L_W/ one hand towel_Sterile_30EA/CS
GRI Medical & Electronic Technology Co., Ltd.
GH90-8020-S1
In Commercial Distribution

  • 26931918196432 ()
  • 16931918196435 ()


  • Surgical gown, single-use

Alleset - 16931918168340

Surgical Gown_i500_Non-Reinforced_L_W/ one hand towel_Sterile_30EA/CS
GRI Medical & Electronic Technology Co., Ltd.
i90-8020-S1
In Commercial Distribution

  • 26931918168347 ()
  • 16931918168340 ()


  • Surgical gown, single-use

Alleset - 16931918178998

Surgical Gown_i500_Non-Reinforced_L_W/ one hand towel_Sterile_30EA/CS
GRI Medical & Electronic Technology Co., Ltd.
SF90-8020-S1
In Commercial Distribution

  • 26931918178995 ()
  • 16931918178998 ()


  • Surgical gown, single-use

BVI - 16931918178325

Gown_Set-In sleeve_Standard_W/ one hand towel_Small_Non-sterile_40ea/cs
GRI Medical & Electronic Technology Co., Ltd.
60300467
In Commercial Distribution

  • 06931918178328 ()
  • 16931918178325 ()


  • Surgical gown, single-use

Alleset - 16931918177700

Gown_Set-In sleeve_Standard_Large_W/ one hand towel_Sterile_20ea/cs
GRI Medical & Electronic Technology Co., Ltd.
92-4020-S1
In Commercial Distribution

  • 26931918177707 ()
  • 16931918177700 ()


  • Surgical gown, single-use

Beaver Visitec Inter - 16931918157078

Surgical Gown_Non-Reinforced_W/ one hand towle_XL_Non-Sterile_32ea/cs
GRI Medical & Electronic Technology Co., Ltd.
60300456
In Commercial Distribution

  • 06931918157071 ()
  • 16931918157078 ()


  • Surgical gown, single-use

Invenio - 16931918150697

Surgical Gown_i500_Non-Reinforced_XXL_W/ one hand towel_Sterile_26EA/CS
GRI Medical & Electronic Technology Co., Ltd.
i90-8040-S1
In Commercial Distribution

  • 26931918150694 ()
  • 16931918150697 ()


  • Surgical gown, single-use

Alleset - 16931918139357

Surgical Gown_Non-Reinforced_L_W/ one hand towel_Sterile_30EA/CS
GRI Medical & Electronic Technology Co., Ltd.
90-8020-S1
In Commercial Distribution

  • 26931918139354 ()
  • 16931918139357 ()


  • Surgical gown, single-use

Beaver Visitec Inter - 16931918137407

Surgical Gown_Non-Reinforced_W/ one hand towle_L_Non-Sterile_36ea/cs
GRI Medical & Electronic Technology Co., Ltd.
60300455
In Commercial Distribution

  • 06931918137400 ()
  • 16931918137407 ()


  • Surgical gown, single-use

Alleset - 16931918131870

Surgical Gown_i500_Non-Reinforced_XL_W/ one hand towel_Sterile_28EA/CS
GRI Medical & Electronic Technology Co., Ltd.
i90-8030-S1
In Commercial Distribution

  • 26931918131877 ()
  • 16931918131870 ()


  • Surgical gown, single-use

Beaver Visitec Inter - 16931918127255

Surgical Gown_Non-Reinforced_W/ one hand towle_M_Non-Sterile_36ea/cs
GRI Medical & Electronic Technology Co., Ltd.
60300454
In Commercial Distribution

  • 06931918127258 ()
  • 16931918127255 ()


  • Surgical gown, single-use

Alleset - 16931918152110

Surgical Gown_Non-Reinforced_XL_W/ one hand towel_Sterile_28EA/CS
GRI Medical & Electronic Technology Co., Ltd.
GH90-8030-S1
In Commercial Distribution

  • 26931918152117 ()
  • 16931918152110 ()


  • Surgical gown, single-use

Alleset - 16931918144764

Surgical Gown_i500_Non-Reinforced_XL_W/ one hand towel_Sterile_28EA/CS
GRI Medical & Electronic Technology Co., Ltd.
SF90-8030-S1
In Commercial Distribution

  • 26931918144761 ()
  • 16931918144764 ()


  • Surgical gown, single-use

BVI - 16931918142777

Surgical Gown_Non-Reinforced_W/ one hand towle_S_Non-Sterile_28ea/cs
GRI Medical & Electronic Technology Co., Ltd.
60300469
In Commercial Distribution

  • 06931918142770 ()
  • 16931918142777 ()


  • Surgical gown, single-use

MDT Diamond Coated Dental Flexible Strips - 17291046701000

One Side Perforated ExtraFineDiamond Strip 3.75
M.D.T. - MICRO DIAMOND TECHNOLOGIES LTD.
OSP-37XF-01
In Commercial Distribution

  • 17291046701000 ()
OSP-37XF

  • Dental abrasive strip, reusable

MIS - 07290109016375

UNO One piece implant insertion tool
MIS Implants Technologies Ltd.
MT-HKO21
Not in Commercial Distribution

  • 07290109016375 ()
MT-HKO21

  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable

MIS - 07290109016368

UNO One piece implant long key
MIS Implants Technologies Ltd.
MT-HKL21
Not in Commercial Distribution

  • 07290109016368 ()
MT-HKL21

  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable

MIS - 07290109014647

UNO One piece implant short key
MIS Implants Technologies Ltd.
MT-RKS15
Not in Commercial Distribution

  • 07290109014647 ()
MT-RKS15

  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable

MIS - 07290109014630

UNO One piece implant long key
MIS Implants Technologies Ltd.
MT-RKL21
Not in Commercial Distribution

  • 07290109014630 ()
MT-RKL21

  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable

BioPro - M20922861

ONE PIECE THUMB STEM RASP 8.5MM
BIOPRO, INC.
22861
In Commercial Distribution

  • M20922861 ()


  • Surgical implant/trial-implant/sizer holder, reusable

BioPro - M20922860

ONE PIECE THUMB STEM RASP 7.5MM
BIOPRO, INC.
22860
In Commercial Distribution

  • M20922860 ()


  • Surgical implant/trial-implant/sizer holder, reusable

Crestone One Piece Implant ø3.50 L16mm - 07290118140689

Crestone One Piece Implant ø3.50 L16mm
NOGA MEDICAL PRODUCTS LTD
B
In Commercial Distribution

  • 07290118140689 ()
IC1-35016

  • Dental implant system

Crestone One Piece Implant ø3.50 L13mm - 07290118140672

Crestone One Piece Implant ø3.50 L13mm
NOGA MEDICAL PRODUCTS LTD
B
In Commercial Distribution

  • 07290118140672 ()
IC1-35013

  • Dental implant system
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