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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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Boditech Med Inc.
FPRR001
In Commercial Distribution

  • 08806133032008 ()
FPRR001

  • Faecal occult blood immunoassay analyser IVD, semi-automated
Anastoclip Atraumatic Forceps, 20cm
Lemaitre Vascular, Inc.
4001-07
In Commercial Distribution

  • 00840663107285 ()
4001-07

  • Clip forceps
Anastoclip Atraumatic Forceps, 18cm
Lemaitre Vascular, Inc.
4001-06
In Commercial Distribution

  • 00840663102419 ()
4001-06

  • Clip forceps
STERILE COTTON BALLS LARGE 5/P
MEDLINE INDUSTRIES, INC.
DYND73032
In Commercial Distribution

  • 40080196469452 ()
  • 10080196469451 ()
DYND73032

  • Cotton wool ball, sterile
Tissue Microarray System
SAKURA FINETEK U.S.A., INC.
8010
In Commercial Distribution

  • 00615233081735 ()
8010

  • Tissue microarray kit
anti-IgG Rabbit Monoclonal Antibody [RM116], 10 RTU capsules
SAKURA FINETEK U.S.A., INC.
8383-C010
In Commercial Distribution

  • 00615233001979 ()
8383-C010

  • Human immunoglobulin G (IgG) rabbit conjugate antibody reagent IVD
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
The HAMA IgG ELISA Test System is a direct enzyme-linked immunosorbent assay for the detection and semi-quantitation of human antibodies to mouse IgG (HAMA). The presence of human anti-mouse antibody (HAMA) has been associated with patients receiving injections of murine monoclonal antibody for diagnostic and/or therapeutic purposes.
ZEUS SCIENTIFIC, INC.
6401
In Commercial Distribution

  • 00845533001335 ()
6401

  • Human immunoglobulin G (IgG) murine conjugate antibody reagent IVD
LARGE RAYON BALLS STERILE 10/PKG
CENTURION MEDICAL PRODUCTS CORPORATION
LRB102
In Commercial Distribution

  • 50653160051242 ()
  • 00653160051247 ()
LRB102

  • Cotton wool ball, sterile
MEDIUM RAYON BALLS STERILE 3/PKG
CENTURION MEDICAL PRODUCTS CORPORATION
RB32
In Commercial Distribution

  • 50653160005047 ()
  • 00653160005042 ()
RB32

  • Cotton wool ball, sterile
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