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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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UROCORE 14GX150MM
H.S. HOSPITAL SERVICE SPA
UROCORE
In Commercial Distribution

  • 38033003348308 ()
  • 08033003348307 ()

  • Length: 150 Millimeter
  • Needle Gauge: 14 Gauge
UC 1415

  • Prostate biopsy needle
No Description
Inmedico A/S
USB350-B
Not in Commercial Distribution

  • 05713557000113 ()


  • Tone audiometer, manual
  • Tone audiometer, automated
  • Tone audiometer
No Description
Inmedico A/S
USB330
Not in Commercial Distribution

  • 05713557000106 ()


  • Tone audiometer, manual
  • Tone audiometer, automated
  • Tone audiometer
No Description
Inmedico A/S
USB310
Not in Commercial Distribution

  • 05713557000090 ()


  • Tone audiometer, automated
  • Tone audiometer, manual
  • Tone audiometer
No Description
Inmedico A/S
SM930
Not in Commercial Distribution

  • 05713557000045 ()


  • Tone audiometer
  • Tone audiometer, automated
  • Tone audiometer, manual
No Description
Inmedico A/S
SM920-P
Not in Commercial Distribution

  • 05713557000038 ()


  • Tone audiometer, automated
  • Tone audiometer, manual
  • Tone audiometer
No Description
Inmedico A/S
SM950
Not in Commercial Distribution

  • 05713557000052 ()


  • Tone audiometer
  • Tone audiometer, automated
  • Tone audiometer, manual
No Description
Boditech Med Inc.
FPRR001
In Commercial Distribution

  • 08806133032008 ()
FPRR001

  • Faecal occult blood immunoassay analyser IVD, semi-automated
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
Tissue Microarray System
SAKURA FINETEK U.S.A., INC.
8010
In Commercial Distribution

  • 00615233081735 ()
8010

  • Tissue microarray kit
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