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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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Tissue-Tek Genie® - 00615233001962

anti-IgG Rabbit Monoclonal Antibody [RM116], 1 RTU cartridge
SAKURA FINETEK U.S.A., INC.
8383-M250
In Commercial Distribution

  • 00615233001962 ()
8383-M250

  • Human immunoglobulin G (IgG) rabbit conjugate antibody reagent IVD

Tissue-Tek Genie® - 00615233001894

anti-Tryptase Rabbit Monoclonal Antibody [EP259], 10 RTU capsules
SAKURA FINETEK U.S.A., INC.
8372-C010
In Commercial Distribution

  • 00615233001894 ()
8372-C010

  • Tryptase IVD, antibody

Tissue-Tek Genie® - 00615233001887

anti-Tryptase Rabbit Monoclonal Antibody [EP259], 1 RTU cartridge
SAKURA FINETEK U.S.A., INC.
8372-M250
In Commercial Distribution

  • 00615233001887 ()
8372-M250

  • Tryptase IVD, antibody

Tissue-Tek Genie® - 00615233001870

anti-Melanoma Pan Antibody Cocktail [HMB45/EP43/T311], 1 RTU cartridge
SAKURA FINETEK U.S.A., INC.
8371-M250
In Commercial Distribution

  • 00615233001870 ()
8371-M250

  • Melanoma specific protein IVD, antibody

Tissue-Tek Genie® - 00615233001863

anti-Melanoma Pan Antibody Cocktail [HMB45/EP43/T311], 10 RTU capsules
SAKURA FINETEK U.S.A., INC.
8371-C010
In Commercial Distribution

  • 00615233001863 ()
8371-C010

  • Melanoma specific protein IVD, antibody

Syntec End Cap - 04719873533510

Syntec End Cap φ13 x L15mm
SYNTEC SCIENTIFIC CORPORATION
S880060-15
In Commercial Distribution

  • 04719873533510 ()


  • Bone nail end-cap, non-sterile

Syntec End Cap - 04719873533503

Syntec End Cap φ13 x L10mm
SYNTEC SCIENTIFIC CORPORATION
S880060-10
In Commercial Distribution

  • 04719873533503 ()


  • Bone nail end-cap, non-sterile

Syntec End Cap - 04719873533497

Syntec End Cap φ13 x L5mm
SYNTEC SCIENTIFIC CORPORATION
S880060-5
In Commercial Distribution

  • 04719873533497 ()


  • Bone nail end-cap, non-sterile

Syntec Femoral Nail System - 04719873533480

Syntec End Cap φ13 x L15mm
SYNTEC SCIENTIFIC CORPORATION
T880060-15
In Commercial Distribution

  • 04719873533480 ()


  • Bone nail end-cap, non-sterile

Syntec Femoral Nail System - 04719873533473

Syntec End Cap φ13 x L10mm
SYNTEC SCIENTIFIC CORPORATION
T880060-10
In Commercial Distribution

  • 04719873533473 ()


  • Bone nail end-cap, non-sterile
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