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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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Orthopaedic & Spine Development (OSD) - 03760178394802

Instrument to use with ORIGIN implants
ORTHOPAEDIC & SPINE DEVELOPMENT
A-CPL-0002
In Commercial Distribution

  • 03760178394802 ()


  • General internal orthopaedic fixation system implantation kit

Gamma Lewis Blood Group Substance - 10888234000853

Gamma Lewis Blood Group Substance is intended for use in assistance in the identification of unexpected blood group antibodies by neutralizing anti-Lea and anti-Leb activity in serum or plasma. Gamma Lewis Blood Group Substance is a standardized solution of human Lea and Leb blood group substances in phosphate-buffered saline. This package configuration is one (1) vial of 2 mL volume.
IMMUCOR, INC.
0007702
In Commercial Distribution

  • 10888234000853 ()
0007702

  • Immunoglobulin removal reagent IVD

Gamma P1 Blood Group Substance - 10888234000846

Gamma P1 Blood Group Substance is intended for use in assistance in the identification of unexpected blood group antibodies by neutralizing anti-P1 activity in serum or plasma. Gamma P1 Blood Group Substance is a standardized solution of avian P1 blood group substance in phosphate-buffered saline. This package configuration is one (1) vial of 2 mL volume.
IMMUCOR, INC.
0007700
In Commercial Distribution

  • 10888234000846 ()
0007700

  • Immunoglobulin removal reagent IVD

JBAIDS - 00851458005075

JBAIDS IVD Influenza A Subtyping Kit
BIOFIRE DEFENSE, LLC
JRPD-ASY-0138
Not in Commercial Distribution

  • 00851458005075 ()
JRPD-ASY-0138

  • Influenza A virus H5N1 subtype (avian influenza) nucleic acid IVD, kit, nucleic acid technique (NAT)

Simplexa™ Influenza A H1N1 (2009) - 20816101025521

No Description
DIASORIN MOLECULAR LLC
MOL2500
Not in Commercial Distribution

  • 20816101025521 ()


  • Influenza A virus H1N1 subtype (swine influenza) nucleic acid IVD, kit, nucleic acid technique (NAT)

Cemented Origin Stem - 09348215054663

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-42-0803
In Commercial Distribution

  • 09348215054663 ()


  • Uncoated femoral stem prosthesis, one-piece

Cemented Origin Stem - 09348215054649

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-42-1602
In Commercial Distribution

  • 09348215054649 ()


  • Uncoated femoral stem prosthesis, one-piece

Cemented Origin Stem - 09348215054601

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-42-1202
In Commercial Distribution

  • 09348215054601 ()


  • Uncoated femoral stem prosthesis, one-piece

Cemented Origin Stem - 09348215054588

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-42-1002
In Commercial Distribution

  • 09348215054588 ()


  • Uncoated femoral stem prosthesis, one-piece

Cemented Origin Stem - 09348215054564

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-42-0802
In Commercial Distribution

  • 09348215054564 ()


  • Uncoated femoral stem prosthesis, one-piece
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