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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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NAMIC - 10193489047516

MTS LEFT HEART KIT-MEDINA COM HOSP
MEDLINE INDUSTRIES, INC.
60137612
In Commercial Distribution

  • 20193489047513 ()
  • 10193489047516 ()
60137612

  • Angiography kit

NAMIC - 10193489043488

MTS LEFT HEART KIT EVANGELICAL COM
MEDLINE INDUSTRIES, INC.
60052241
In Commercial Distribution

  • 20193489043485 ()
  • 10193489043488 ()
60052241

  • Angiography kit

CoreValve™ - 00643169565630

DEL SYS DCS-C4-18F-23US COM 23 NP
MEDTRONIC COREVALVE LLC
DCS-C4-18F-23US
Not in Commercial Distribution

  • 00643169565630 ()

  • Valve Size 23 MM


  • Aortic transcatheter heart valve bioprosthesis, stent-like framework

INTENSA - M368IN597GCOM1

RECL OB II ARM CAP COM
GF HEALTH PRODUCTS, INC.
IN597GCOM
In Commercial Distribution

  • M368IN597GCOM1 ()


  • Reclining chair

Atellica IM aHBs2 - 00630414301273

Anti-HBs2 (aHBs2) - Atellica IM - RGT - 200T
Siemens Healthcare Diagnostics Inc.
11207255
In Commercial Distribution

  • 00630414301273 ()
11207255

  • Hepatitis B virus surface total antibody IVD, kit, chemiluminescent immunoassay

Atellica IM aHBcM - 00630414301266

HBc IgM (aHBcM) - Atellica IM - RGT - 100T
Siemens Healthcare Diagnostics Inc.
11207249
In Commercial Distribution

  • 00630414301266 ()
11207249

  • Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay

ADVIA Centaur aHBe2 50T Kit - 00630414167923

Anti-HBe2 (aHBe2) – ADVIA Centaur – RGT 50T
Siemens Healthcare Diagnostics Inc.
10720831
In Commercial Distribution

  • 00630414167923 ()
10720831

  • Hepatitis B virus e-antigen total antibody IVD, kit, chemiluminescent immunoassay

IMMULITE® 2000 Systems aBC Calibration Verification Material Anti-HBC - 00630414978017

Anti-HBc IgM CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10373676
In Commercial Distribution

  • 00630414978017 ()
L2MCCVM

  • Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control

IMMULITE® 2000 Systems BcM Anti-HBc IgM - 00630414977737

BcM Anti-HBc IgM Kit 200 Test
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10488616
In Commercial Distribution

  • 00630414977737 ()
L2KMC2(D)

  • Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay

IMMULITE®/IMMULITE®1000 Systems BcM Anti-HBc IgM - 00630414977720

BcM Anti-HBc IgM Kit 100 Test
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10488615
Not in Commercial Distribution

  • 00630414977720 ()
LKMC1(D)

  • Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
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