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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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Microplasty Tibial Template Right Medial
Biomet Uk Ltd
32-422853
In Commercial Distribution

  • 05019279403882 ()

  • B
32-422853

  • Surgical implant template, reusable
Tubigrip B Beige x 10m
Mölnlycke Health Care AB
1449
In Commercial Distribution

  • 07332551449780 ()
  • 07332551449797 ()
  • 07332551948184 ()

  • B


  • Tubular support bandage, Hevea-latex
Tubigrip B Natural x 10m
Mölnlycke Health Care AB
1436
In Commercial Distribution

  • 07332551449421 ()
  • 07332551449438 ()
  • 07332551947903 ()

  • B


  • Tubular support bandage, Hevea-latex
Tubigrip B Nat 1m 5x12pcs
Mölnlycke Health Care AB
1520
In Commercial Distribution

  • 07332551945879 ()
  • 07332551448684 ()
  • 07332551448707 ()

  • B


  • Tubular support bandage, Hevea-latex
B&B Bur Block
Hager & Meisinger Gesellschaft mit beschränkter Haftung
0BB23
In Commercial Distribution

  • E0HM740BB231 ()
0BB23

  • Diamond dental bur, reusable
Clostridium difficile Antitoxin, 3 mL
MARDX DIAGNOSTICS, INC.
B1029-70C
In Commercial Distribution

  • 05391516748858 ()
B1029-70C

  • Clostridium difficile antigen IVD, reagent
Toxi-Titer Diluent, 50 mL
MARDX DIAGNOSTICS, INC.
B1029-70B
In Commercial Distribution

  • 05391516748841 ()
B1029-70B

  • Clostridium difficile antigen IVD, reagent
2-3% Reagent Red Blood Cells for ABO Reverse Grouping, ALBAcyte Orr Cells, for tube techniques.
ALBA BIOSCIENCE LIMITED
Z421U
In Commercial Distribution

  • 05060242471155 ()


  • Group O Rh (D) negative reagent red blood cell IVD, antigen
The Procleix Ultrio Elite Assay is a qualitative in vitro nucleic acid amplification test for the detection of human immunodeficiency virus type 1 and type 2 (HIV-1 and HIV-2) RNA, hepatitis C virus (HCV) RNA, and/or hepatitis B virus (HBV) DNA in plasma and serum specimens from human donors.
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Positive Calibrator Kit
In Commercial Distribution

  • 00859882007696 ()


  • HIV1/HIV2/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
The Procleix Ultrio Elite Assay is a qualitative in vitro nucleic acid amplification test for the detection of human immunodeficiency virus type 1 and type 2 (HIV-1 and HIV-2) RNA, hepatitis C virus (HCV) RNA, and/or hepatitis B virus (HBV) DNA in plasma and serum specimens from human donors.
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Negative Calibrator Kit
In Commercial Distribution

  • 00859882007689 ()


  • HIV1/HIV2/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
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