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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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Maquet Rolite - 03700712422707

ROL VCSII40SF B
MAQUET SAS
ARDROL309039A
In Commercial Distribution

  • 03700712422707 ()


  • Mobile examination/treatment room light

ROLITE VOLISTA ACCESS - 03700712400828

VCS60 ROL B
MAQUET SAS
ARDROL309029A
Not in Commercial Distribution

  • 03700712400828 ()


  • Transportable medical equipment stand, non-powered

ROLITE VOLISTA ACCESS - 03700712400804

VCS40 ROL B
MAQUET SAS
ARDROL309028A
Not in Commercial Distribution

  • 03700712400804 ()


  • Transportable medical equipment stand, non-powered

Quick coupling - E27658617240

Quick coupling B
SIRONA Dental Systems GmbH
5861724
In Commercial Distribution

  • E27658617240 ()


  • Dental power tool handpiece motorless component

ACS - 00191072184948

CV B PACK
AMERICAN CONTRACT SYSTEMS, INC.
TNCB10AK
In Commercial Distribution

  • 00191072184948 ()


  • General surgical procedure kit, non-medicated, single-use

ACS - 00191072154859

ORTHO PACK B
AMERICAN CONTRACT SYSTEMS, INC.
AHOR32S
In Commercial Distribution

  • 00191072154859 ()


  • General surgical procedure kit, non-medicated, single-use

ACS - 00191072073426

ORTHO PACK B
AMERICAN CONTRACT SYSTEMS, INC.
AHOR32P
In Commercial Distribution

  • 00191072073426 ()


  • General surgical procedure kit, non-medicated, single-use

ACS - 00191072068774

CV B PACK
AMERICAN CONTRACT SYSTEMS, INC.
TNCB10AD
In Commercial Distribution

  • 00191072068774 ()


  • General surgical procedure kit, non-medicated, single-use

AspireAssist Companion, Magenta-LANG B - 10857808005136

Companion, Magenta-LANG B
ASPIRE BARIATRICS, INC.
100-0014-LANG B
In Commercial Distribution

  • 10857808005136 ()
100-0014-LANG B

  • Gastrostomy aspiration system gravity set

AspireAssist Companion, Blue-LANG B - 10857808005105

Companion, Blue-LANG B
ASPIRE BARIATRICS, INC.
100-0013-LANG B
In Commercial Distribution

  • 10857808005105 ()
100-0013-LANG B

  • Gastrostomy aspiration system gravity set

ACS - 00191072011695

CV B PACK
AMERICAN CONTRACT SYSTEMS, INC.
TNCB10AC
In Commercial Distribution

  • 00191072011695 ()


  • General surgical procedure kit, non-medicated, single-use

ACS - 00191072177506

ORTHO PACK B
AMERICAN CONTRACT SYSTEMS, INC.
AHOR32T
In Commercial Distribution

  • 00191072177506 ()


  • General surgical procedure kit, non-medicated, single-use

Avalign - 00190776040147

Brewster Retractor "B"
Avalign Technologies, Inc.
VM29-3343
In Commercial Distribution

  • 00190776040147 ()


  • Hand-held surgical retractor, reusable

ACS - 00191072232991

CV B PACK
AMERICAN CONTRACT SYSTEMS, INC.
TNCB10AM
In Commercial Distribution

  • 00191072232991 ()


  • General surgical procedure kit, non-medicated, single-use

Medline Industries, Inc. - 10884389851807

L&B CDS-LF
MEDLINE INDUSTRIES, INC.
CDS980273D
In Commercial Distribution

  • 10884389851807 ()
  • 40884389851808 ()
CDS980273D

  • General surgical procedure kit, medicated

ELEVATOR - 00888118066565

ROOT, COGSWELL B
KLS-Martin L.P.
42-007-00-07
In Commercial Distribution

  • 00888118066565 ()


  • Dental elevator, tooth/root

Northeast Laboratory Services - 00810144911281

Nitrate Reagent B
Northeast Laboratory Services, Inc.
1
In Commercial Distribution

  • 00810144911281 ()
X1260

  • Nitrate reduction microbial reagent IVD

Northeast Laboratory Services - 00810144911229

Voges-Proskauer - Reagent B
Northeast Laboratory Services, Inc.
1
In Commercial Distribution

  • 00810144911229 ()
X1225

  • Voges-Proskauer (VP) microbial reagent IVD

CARDINAL HEALTH - 10198956015579

CARDIAC PART B
Cardinal Health 200, LLC
SCV73CPK35
In Commercial Distribution

  • 50198956015577 ()
  • 10198956015579 ()
SCV73CPK35

  • Cardiothoracic surgical procedure kit, non-medicated, single-use

Orthopedic Extension - 00887761972094

Extension pad B
Baxter Medical Systems GmbH + Co. KG
1902847
In Commercial Distribution

  • 00887761972094 ()


  • Operating table orthopaedic extension, non-powered

Pads - 00887761969469

Pad 215x100 B
Baxter Medical Systems GmbH + Co. KG
1851990
Not in Commercial Distribution

  • 00887761969469 ()


  • Operating table patient pressure distribution pad, reusable

ANKYLOS® - 07392532219108

Trephine Drill B
Dentsply Implants Manufacturing GmbH
31034010
In Commercial Distribution

  • 07392532219108 ()
31034010

  • Pin/post dental drill bit

ZSFab Cervical Surgical Instrument - 00810136251944

Trails caddy B
Zsfab, Inc.
Trails caddy B
In Commercial Distribution

  • 00810136251944 ()


  • Metallic spinal interbody fusion cage

Medline Industries, Inc. - 10198459136757

CRANE PACK B
MEDLINE INDUSTRIES, INC.
DYNJ87423A
In Commercial Distribution

  • 10198459136757 ()
DYNJ87423A

  • General surgical procedure kit, non-medicated, single-use

MEDLINE INDUSTRIES, INC. - 10198459413599

O B PACK
MEDLINE INDUSTRIES, INC.
DYNJ85322B
In Commercial Distribution

  • 40198459413590 ()
  • 10198459413599 ()
DYNJ85322B

  • General surgical procedure kit, non-medicated, single-use

Medline Industries, Inc. - 10198459224294

CYSTO TRAY B
MEDLINE INDUSTRIES, INC.
DYNJ88981
In Commercial Distribution

  • 40198459224295 ()
  • 10198459224294 ()
DYNJ88981

  • General surgical procedure kit, non-medicated, single-use

Medline Industries, Inc. - 10198459327094

PACK B CARDIAC
MEDLINE INDUSTRIES, INC.
DYNJT3274
In Commercial Distribution

  • 40198459327095 ()
  • 10198459327094 ()
DYNJT3274

  • General surgical procedure kit, non-medicated, single-use

Medline Industries, Inc. - 10198459268076

HEART B PACK
MEDLINE INDUSTRIES, INC.
DYNJ24764O
In Commercial Distribution

  • 40198459268077 ()
  • 10198459268076 ()
DYNJ24764O

  • General surgical procedure kit, non-medicated, single-use

Medline Industries, Inc. - 10198459274084

L&B PACK
MEDLINE INDUSTRIES, INC.
DYNJ52905C
In Commercial Distribution

  • 40198459274085 ()
  • 10198459274084 ()
DYNJ52905C

  • General surgical procedure kit, non-medicated, single-use

Medline Industries, Inc. - 10198459281570

CARDIO B PACK
MEDLINE INDUSTRIES, INC.
DYNJ36052Q
In Commercial Distribution

  • 40198459281571 ()
  • 10198459281570 ()
DYNJ36052Q

  • General surgical procedure kit, non-medicated, single-use

Medline Industries, Inc. - 10198459271908

CRANE PACK B
MEDLINE INDUSTRIES, INC.
DYNJ84105A
In Commercial Distribution

  • 10198459271908 ()
DYNJ84105A

  • General surgical procedure kit, non-medicated, single-use

CARDINAL HEALTH - 10197106863053

A B TRAY
Cardinal Health 200, LLC
17-7937A
In Commercial Distribution

  • 50197106863051 ()
  • 10197106863053 ()
17-7937A

  • General surgical procedure kit, non-medicated, single-use

BASE - 00887517700407

BASE Guide, B
Nuvasive, Inc.
6950302
In Commercial Distribution

  • 00887517700407 ()


  • Surgical instrument/implant depth limiter, reusable

CARDINAL HEALTH - 10197106814710

CYSTO TRAY B
Cardinal Health 200, LLC
SOTOCCTMS1
In Commercial Distribution

  • 50197106814718 ()
  • 10197106814710 ()
SOTOCCTMS1

  • Urological surgical procedure kit, non-medicated, single-use

Medline Industries, Inc. - 10198459130120

OPEN HEART B
MEDLINE INDUSTRIES, INC.
DYNJ85781A
In Commercial Distribution

  • 40198459130121 ()
  • 10198459130120 ()
DYNJ85781A

  • General surgical procedure kit, non-medicated, single-use

Medline Industries, Inc. - 10198459087196

OMF/FLAP B
MEDLINE INDUSTRIES, INC.
DYNJ83992B
In Commercial Distribution

  • 10198459087196 ()
DYNJ83992B

  • General surgical procedure kit, non-medicated, single-use

FAC-3 - Class B - 00766588150253

FAC-3 - Class B
Certified Safety Manufacturing, Inc.
K615-025
In Commercial Distribution

  • 00766588150253 ()
K615-025

  • Adhesive bandage
  • Dressing-fixation skin adhesive tape, non-silicone
  • Non-rebreathing valve, single-use
  • Wound-nonadherent dressing, absorbent, non-antimicrobial
  • First aid kit, medicated
  • Non-woven gauze pad
  • Eye pad
  • Endothermic cold therapy pack
  • Non-woven gauze roll/sheet

CARDINAL HEALTH - 10197106581742

KIT, TURNOVER B
Cardinal Health 200, LLC
ORC406104A
In Commercial Distribution

  • 50197106581740 ()
  • 10197106581742 ()
ORC406104A

  • General surgical procedure kit, non-medicated, single-use

CARDINAL HEALTH - 10197106650400

KIT, TURNOVER B
Cardinal Health 200, LLC
ORC4061041
In Commercial Distribution

  • 50197106650408 ()
  • 10197106650400 ()
ORC4061041

  • General surgical procedure kit, non-medicated, single-use

Navident - 07540209955778

Jaw Tracker B
Claronav Inc
955-ND-JTVB
In Commercial Distribution

  • 07540209955778 ()
955-ND-JTVB

  • Surgical planning/navigation-enhancement system

Medline Industries, Inc. - 10198459024863

CARDIAC CABG B
MEDLINE INDUSTRIES, INC.
DYNJ908121C
In Commercial Distribution

  • 10198459024863 ()
DYNJ908121C

  • General surgical procedure kit, medicated

Medline Industries, Inc. - 10198459158643

CV A & B
MEDLINE INDUSTRIES, INC.
DYNJ84590A
In Commercial Distribution

  • 10198459158643 ()
DYNJ84590A

  • General surgical procedure kit, non-medicated, single-use

Medline Industries, Inc. - 10198459039065

CRANE PACK B
MEDLINE INDUSTRIES, INC.
DYNJ87423
In Commercial Distribution

  • 10198459039065 ()
DYNJ87423

  • General surgical procedure kit, non-medicated, single-use

Medline Industries, Inc. - 10198459212789

LAVH PART B
MEDLINE INDUSTRIES, INC.
DYNJV0312F
In Commercial Distribution

  • 40198459212780 ()
  • 10198459212789 ()
DYNJV0312F

  • General surgical procedure kit, non-medicated, single-use

Medline Industries, Inc. - 10198459204890

TVC B PACK
MEDLINE INDUSTRIES, INC.
DYNJ58586C
In Commercial Distribution

  • 40198459204891 ()
  • 10198459204890 ()
DYNJ58586C

  • General surgical procedure kit, non-medicated, single-use

Medline Industries, Inc. - 10198459197895

OPEN HEART B
MEDLINE INDUSTRIES, INC.
DYNJ906018F
In Commercial Distribution

  • 10198459197895 ()
DYNJ906018F

  • General surgical procedure kit, non-medicated, single-use

VEO® Lateral Interbody Fusion System - 00840996132701

LATERAL,DILATOR B
Choice Spine, LP
20-2060
In Commercial Distribution

  • 00840996132701 ()


  • Polymeric spinal interbody fusion cage

Medline Industries, Inc. - 10198459016509

L&B PACK
MEDLINE INDUSTRIES, INC.
DYNJ52905B
In Commercial Distribution

  • 40198459016500 ()
  • 10198459016509 ()
DYNJ52905B

  • General surgical procedure kit, non-medicated, single-use

Medline Industries, Inc. - 10198459015038

CV B PACK
MEDLINE INDUSTRIES, INC.
DYNJ61503F
In Commercial Distribution

  • 10198459015038 ()
DYNJ61503F

  • General surgical procedure kit, non-medicated, single-use

ResiCem - E23532280

RESICEM PRIMER B
SHOFU DENTAL CORPORATION
3228
In Commercial Distribution

  • E23532280 ()
3228

  • Dental composite resin
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