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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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Alinity s HBsAg Assay Control Kit
Abbott Ireland Diagnostics
06P0213
In Commercial Distribution

  • 00380740136796 ()
06P0213

  • Hepatitis B virus surface antigen IVD, control
Blood Grouping Reagent Anti-B (Murine Monoclonal) formulated for Automated Systems, Beckman Coulter® PK® Systems
DIAGAST
27302
In Commercial Distribution

  • 23661562273021 ()
  • 13661562273024 ()
27302

  • Anti-B red blood cell grouping IVD, antibody
Blood Grouping Reagent Anti-B (Murine Monoclonal) formulated for Automated Systems, Beckman Coulter® PK® Systems
DIAGAST
17302
In Commercial Distribution

  • 23661562173024 ()
  • 13661562173027 ()
17302

  • Anti-B red blood cell grouping IVD, antibody
Blood Grouping Reagent, Anti-B (Murine Monoclonal) (9621A8) - This reagent is designed to determine the presence of ABO system blood group antigen B on the surface of human red blood cells by manual tube method.
DIAGAST
210521
In Commercial Distribution

  • 23661562105216 ()
  • 13661562105219 ()
210521

  • Anti-B red blood cell grouping IVD, antibody
Influenza B Virus Control Stock
DIAGNOSTIC HYBRIDS, INC.
20-4720010
In Commercial Distribution

  • 30014613338529 ()
20-4720010

  • Influenza B virus antigen IVD, control
Blood Grouping Reagent Anti-B (ABO2); Seraclone® Murine Monoclonal (B005); for tube test; 10x10ml
Bio-Rad Medical Diagnostics GmbH
801350100
In Commercial Distribution

  • 07611969950119 ()
801350100

  • Anti-B red blood cell grouping IVD, antibody
Aptima® HBV Quant Assay Controls Kit.
Hologic, Inc.
KIT, CONTROLS, HBV, VL, US IVD
In Commercial Distribution

  • 15420045506763 ()
PRD-03869

  • Hepatitis B virus nucleic acid IVD, control
Alinity m HBV CTRL Kit
ABBOTT MOLECULAR INC.
08N47-085
In Commercial Distribution

  • 00884999047815 ()
08N47-085

  • Hepatitis B virus nucleic acid IVD, control
Abbott RealTime HBV Control Kit
ABBOTT MOLECULAR INC.
2N40-80
In Commercial Distribution

  • 00884999003064 ()
2N40-80

  • Hepatitis B virus nucleic acid IVD, control
50PSI PRST COM AIR GAS REG CGA346 MRI
OHIO MEDICAL, LLC
GR-346-DCXX-XXM
In Commercial Distribution

  • 00628101618247 ()
GR-346-DCXX-XXM

  • Non-fixed medical gas cylinder regulator
MTO LEFT HEART KIT PARMA COM GEN HOSP
MEDLINE INDUSTRIES, INC.
651621415
In Commercial Distribution

  • 10193489076363 ()
651621415

  • Angiography kit
MTO LEFT HEART W/DT BOULDER COM HOSP
MEDLINE INDUSTRIES, INC.
650305414
In Commercial Distribution

  • 10193489075151 ()
650305414

  • Angiography kit
MTO 3 WAY MANIFOLD KIT PARMA COM GEN
MEDLINE INDUSTRIES, INC.
601621410
In Commercial Distribution

  • 20193489071884 ()
  • 10193489071887 ()
601621410

  • Angiography kit
MTO LEFT HEART KIT SAN ANGELO COM MED
MEDLINE INDUSTRIES, INC.
60010991
In Commercial Distribution

  • 20193489040439 ()
  • 10193489040432 ()
60010991

  • Angiography kit
MTO LEFT HEART KIT SEVEN RIVERS COM HOSP
MEDLINE INDUSTRIES, INC.
65193662
In Commercial Distribution

  • 10193489063233 ()
65193662

  • Angiography kit
DEL SYS DCS-C4-18F-US COM 26/29/31 NP
MEDTRONIC COREVALVE LLC
DCS-C4-18F-US
Not in Commercial Distribution

  • 00643169565623 ()


  • Aortic transcatheter heart valve bioprosthesis, stent-like framework
STATION,WIRELESS READY,PULLCORD,BLUE ACT,COM,CONN
Crest Healthcare Supply
116648
In Commercial Distribution

  • B4841166480 ()


  • Nurse call system
COM PLACEM INST DE, #40-30 TIN, DL HNDL
NORDENT MANUFACTURING INC
REPFI40T-30T
In Commercial Distribution

  • 00840018647244 ()


  • Margin finishing dental file/rasp, reusable
COM PLACE INST DE LR 2 TIN DL-
NORDENT MANUFACTURING INC
REPFILR2T
In Commercial Distribution

  • 00840018637689 ()


  • Margin finishing dental file/rasp, reusable
COM PLACM INST DE #5 TIN STD H
NORDENT MANUFACTURING INC
PFI5T
In Commercial Distribution

  • 00840018636002 ()


  • Margin finishing dental file/rasp, reusable
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