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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 - 03700712432522

ROLM EZEA30SF TK B
MAQUET SAS
ARDROL309057A
In Commercial Distribution

  • 03700712432522 ()


  • Mobile examination/treatment room light

POWERLED TM - 03700712401818

PWD50+ ROL B K3
MAQUET SAS
ARDROL309010A
Not in Commercial Distribution

  • 03700712401818 ()


  • Transportable medical equipment stand, non-powered

POWERLED TM - 03700712401795

PWD30+ ROL B K3
MAQUET SAS
ARDROL309008A
Not in Commercial Distribution

  • 03700712401795 ()


  • Transportable medical equipment stand, non-powered

ROLITE VOLISTA STANDOP - 03700712400880

VST60 AIM ROL B
MAQUET SAS
ARDROL309019A
Not in Commercial Distribution

  • 03700712400880 ()


  • Transportable medical equipment stand, non-powered

ROLITE VOLISTA STANDOP - 03700712400842

VST40 AIM ROL B
MAQUET SAS
ARDROL309017A
Not in Commercial Distribution

  • 03700712400842 ()


  • Transportable medical equipment stand, non-powered

LUCEA LED® - 03700712400743

LCA 50 MOBILE B
MAQUET SAS
ARDLCA309005A
Not in Commercial Distribution

  • 03700712400743 ()


  • Mobile examination/treatment room light

LUCEA LED® - 03700712400729

LCA 100 MOBILE B
MAQUET SAS
ARDLCA309007A
Not in Commercial Distribution

  • 03700712400729 ()


  • Mobile examination/treatment room light

NA - 03700712413675

WPS 21 B TR
MAQUET SAS
ARD569203915
In Commercial Distribution

  • 03700712413675 ()


  • Operating room light

NA - 03700712413668

WPS 21 B ORK
MAQUET SAS
ARD569203916
In Commercial Distribution

  • 03700712413668 ()


  • Operating room light

NA - 03700712413651

WPS 21 B ORT
MAQUET SAS
ARD569203917
In Commercial Distribution

  • 03700712413651 ()


  • Operating room light

NA - 03700712413644

WPS 12 B TR
MAQUET SAS
ARD569203918
In Commercial Distribution

  • 03700712413644 ()


  • Operating room light

NA - 03700712413637

WPS 12 B ORK
MAQUET SAS
ARD569203919
In Commercial Distribution

  • 03700712413637 ()


  • Operating room light

NA - 03700712413620

WPS 12 B ORT
MAQUET SAS
ARD569203920
In Commercial Distribution

  • 03700712413620 ()


  • Operating room light

NA - 03700712413613

WPS 22 B TR
MAQUET SAS
ARD569203921
In Commercial Distribution

  • 03700712413613 ()


  • Operating room light

NA - 03700712413590

WPS 22 B ORT
MAQUET SAS
ARD569203923
In Commercial Distribution

  • 03700712413590 ()


  • Operating room light

NA - 03700712413453

WPS 20 B ORT
MAQUET SAS
ARD569203905
In Commercial Distribution

  • 03700712413453 ()


  • Operating room light

NA - 03700712413446

WPS 20 B ORK
MAQUET SAS
ARD569203904
In Commercial Distribution

  • 03700712413446 ()


  • Operating room light

NA - 03700712413439

WPS 20 B TR
MAQUET SAS
ARD569203903
In Commercial Distribution

  • 03700712413439 ()


  • Operating room light

NA - 03700712413422

WPS 10 B ORT
MAQUET SAS
ARD569203902
In Commercial Distribution

  • 03700712413422 ()


  • Operating room light

NA - 03700712413415

WPS 10 B ORK
MAQUET SAS
ARD569203901
In Commercial Distribution

  • 03700712413415 ()


  • Operating room light

NA - 03700712413408

WPS 10 B TR
MAQUET SAS
ARD569203900
In Commercial Distribution

  • 03700712413408 ()


  • Operating room light

T4 LINE - E27664018270

T4 LINE B 40
SIRONA Dental Systems GmbH
6387018
In Commercial Distribution

  • E27664018270 ()


  • Dental surgical power tool motorized handpiece/set, pneumatic

CARDINAL HEALTH - 10887488659886

CARDIAC SUPPLEMENTAL B PACK
Cardinal Health 200, LLC
PCOCBCNSA
In Commercial Distribution

  • 50887488659884 ()
  • 10887488659886 ()
PCOCBCNSA

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

CARDINAL HEALTH - 10887488657936

KIT,HYSTEROSCOPY,MISSISSIPPI B
Cardinal Health 200, LLC
PBVZHSMBN
In Commercial Distribution

  • 50887488657934 ()
  • 10887488657936 ()
PBVZHSMBN

  • Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use

n.a. - 04048551077016

Obturator, for 27047 B
Karl Storz GmbH & Co. KG
27047BO
In Commercial Distribution

  • 04048551077016 ()


  • Rigid endoscope obturator

n.a. - 04048551075197

Obturator for 27034 B
Karl Storz GmbH & Co. KG
27034BO
In Commercial Distribution

  • 04048551075197 ()


  • Rigid endoscope obturator

CARDINAL HEALTH - 10887488522111

KIT,TOTAL HIP B
Cardinal Health 200, LLC
POMVTBNMG
In Commercial Distribution

  • 50887488522119 ()
  • 10887488522111 ()
POMVTBNMG

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

AutoSelector - 08806139603882

550/B/5.0/60
Ace Medical Co., Ltd.
MVBX60XL
In Commercial Distribution

  • 58806139603887 ()
  • 08806139603882 ()
  • 18806139603889 ()


  • Elastomeric infusion pump system

AutoSelector - 08806139603875

550/B/5.0/30
Ace Medical Co., Ltd.
MVBX30XL
In Commercial Distribution

  • 58806139603870 ()
  • 08806139603875 ()
  • 18806139603872 ()


  • Elastomeric infusion pump system

AutoSelector - 08806139603868

550/B/2.0/60
Ace Medical Co., Ltd.
MVBT60XL
In Commercial Distribution

  • 58806139603863 ()
  • 08806139603868 ()
  • 18806139603865 ()


  • Elastomeric infusion pump system

AutoSelector - 08806139603851

550/B/2.0/30
Ace Medical Co., Ltd.
MVBT30XL
In Commercial Distribution

  • 58806139603856 ()
  • 08806139603851 ()
  • 18806139603858 ()


  • Elastomeric infusion pump system

AutoSelector - 08806139603844

550/B/2.0/15
Ace Medical Co., Ltd.
MVBT15XL
In Commercial Distribution

  • 58806139603849 ()
  • 08806139603844 ()
  • 18806139603841 ()


  • Elastomeric infusion pump system

CARDINAL HEALTH - 10887488572888

STERILE CRANE B PACK
Cardinal Health 200, LLC
SBA41CBWLA
In Commercial Distribution

  • 50887488572886 ()
  • 10887488572888 ()
SBA41CBWLA

  • General surgical procedure kit, medicated

CARDINAL HEALTH - 10887488194769

STERILE O B PACK
Cardinal Health 200, LLC
SMA11OSCTL
In Commercial Distribution

  • 50887488194767 ()
  • 10887488194769 ()
SMA11OSCTL

  • Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use

CARDINAL HEALTH - 10887488192826

YELLOW AIRWAY BUNDLE B
Cardinal Health 200, LLC
SP1MV0798A
In Commercial Distribution

  • 50887488192824 ()
  • 10887488192826 ()
SP1MV0798A

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

Tenure® - D8131146B0

TENURE B ADHESIVE 6mL
DEN-MAT HOLDINGS, LLC
1146B
In Commercial Distribution

  • D8131146B0 ()
1146B

  • Dentine bonding agent/set

CARDINAL HEALTH - 10885425208814

SCISSORS S/B 5.5
Cardinal Health 200, LLC
14-0109A
In Commercial Distribution

  • 50885425208812 ()
  • 10885425208814 ()
14-0109A

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

CARDINAL HEALTH - 10885425547814

STERILE O B PACK
Cardinal Health 200, LLC
SMA51OBUVE
In Commercial Distribution

  • 50885425547812 ()
  • 10885425547814 ()
SMA51OBUVE

  • Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use

CARDINAL HEALTH - 10885425497133

SCISSORS S/B 5.5
Cardinal Health 200, LLC
12-8426
In Commercial Distribution

  • 50885425497131 ()
  • 10885425497133 ()
12-8426

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

ACS - 00191072190796

CARDIAC CUSTOM B PACK
AMERICAN CONTRACT SYSTEMS, INC.
ESCD87A
In Commercial Distribution

  • 00191072190796 ()


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

ACS - 00191072225719

DAVINCI PACK - PART B
AMERICAN CONTRACT SYSTEMS, INC.
PLDA70L
In Commercial Distribution

  • 00191072225719 ()


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

ACS - 00191072236982

OPEN HEART B PACK
AMERICAN CONTRACT SYSTEMS, INC.
UTOH20S
In Commercial Distribution

  • 00191072236982 ()


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

CARDINAL HEALTH - 10887488308395

STERILE CRANIOTOMY B PACK
Cardinal Health 200, LLC
SNE11CBLDH
In Commercial Distribution

  • 50887488308393 ()
  • 10887488308395 ()
SNE11CBLDH

  • Craniotomy kit

CARDINAL HEALTH - 10887488280523

KIT,ANTERIOR CERV B
Cardinal Health 200, LLC
PN41ACCSA
In Commercial Distribution

  • 50887488280521 ()
  • 10887488280523 ()
PN41ACCSA

  • Embolization implant kit

CARDINAL HEALTH - 10887488280479

KIT,LUMBAR DISC B
Cardinal Health 200, LLC
PO41LBCSA
In Commercial Distribution

  • 50887488280477 ()
  • 10887488280479 ()
PO41LBCSA

  • Orthopaedic surgical procedure kit, medicated

CARDINAL HEALTH - 10887488297972

TOTAL KNEE PACK B
Cardinal Health 200, LLC
SOP39TKWCA
In Commercial Distribution

  • 50887488297970 ()
  • 10887488297972 ()
SOP39TKWCA

  • Orthopaedic surgical procedure kit, medicated

Lateral Patient Positioning System - 00190376471327

Loading Base, Pad B
ALPHATEC SPINE, INC.
180-602
In Commercial Distribution

  • 00190376471327 ()


  • Operating table patient pressure distribution pad, reusable

Lateral Patient Positioning System - 00190376484280

Loading Base Pad B
ALPHATEC SPINE, INC.
181-602
In Commercial Distribution

  • 00190376484280 ()


  • Operating table patient pressure distribution pad, reusable

Rhythmia™ Mapping System - 08714729842019

Breakout Box B Out
BOSTON SCIENTIFIC CORPORATION
M004RH12500
In Commercial Distribution

  • 08714729842019 ()


  • Cardiac mapping system

Rhythmia™ Mapping System - 08714729842002

Breakout Box B In
BOSTON SCIENTIFIC CORPORATION
M004RH12000
In Commercial Distribution

  • 08714729842002 ()


  • Cardiac mapping system
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