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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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Fresh Cells - 30014613331391

PMK VIAL/SNAP CAP
DIAGNOSTIC HYBRIDS, INC.
15-308
In Commercial Distribution

  • 30014613331391 ()
15-308

  • Cell culture line IVD

Fresh Cells - 30014613331384

RMK SV5/SV40 TUBE
DIAGNOSTIC HYBRIDS, INC.
14-309
In Commercial Distribution

  • 30014613331384 ()
14-309

  • Cell culture line IVD

Fresh Cells - 30014613331377

RMK TUBE
DIAGNOSTIC HYBRIDS, INC.
14-308
In Commercial Distribution

  • 30014613331377 ()
14-308

  • Cell culture line 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

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

Origin Hip Stem - 09348215053345

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
D111-18-0801
In Commercial Distribution

  • 09348215053345 ()


  • Coated femoral stem prosthesis, modular

Origin Hip Stem - 09348215051822

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
D111-18-1803
In Commercial Distribution

  • 09348215051822 ()


  • Coated femoral stem prosthesis, modular

Origin Hip Stem - 09348215051815

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
D111-18-1603
In Commercial Distribution

  • 09348215051815 ()


  • Coated femoral stem prosthesis, modular

Origin Hip Stem - 09348215051808

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
D111-18-1503
In Commercial Distribution

  • 09348215051808 ()


  • Coated femoral stem prosthesis, modular

Origin Hip Stem - 09348215051792

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
D111-18-1403
In Commercial Distribution

  • 09348215051792 ()


  • Coated femoral stem prosthesis, modular
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