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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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ToRC IgG Assay Protocol File CD, SW4.1_v1
BIO-RAD LABORATORIES, INC.
SW4.1_V1
In Commercial Distribution

  • 00847865010948 ()

  • 1 Each
6651670H

  • Rubella virus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
  • Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
Syphilis IgG Assay Protocol File CD, SW4.1_v1
BIO-RAD LABORATORIES, INC.
SW4.1_v1
In Commercial Distribution

  • 00847865010924 ()

  • 1 Each
6651470E

  • Treponema pallidum immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
CUSTOM SOUND SUITE 4.0 - CD VERSION - ENGLISH
COCHLEAR LIMITED
Z361240
In Commercial Distribution

  • 09321502029599 ()
Z361240

  • Audiometric/hearing device software
CUSTOM SOUND SUITE 4.1 SP3 (US) - CD
COCHLEAR LIMITED
Z540369
In Commercial Distribution

  • 09321502029452 ()
Z540369

  • Audiometric/hearing device software
PROFILE ARM BLACK W/O GAUNTLET C-D
MEDI MANUFACTURING, INC.
CFAMSC53
In Commercial Distribution

  • 00636257025888 ()


  • Compression bandaging kit
INSTRUMENT 85626 CD RED PED PRCSS ELVTR
MEDTRONIC SOFAMOR DANEK, INC.
85626
In Commercial Distribution

  • 00673978062389 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
INSTRUMENT 85621 CD RED TRNS PRCSS ELVTR
MEDTRONIC SOFAMOR DANEK, INC.
85621
In Commercial Distribution

  • 00673978062372 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
INSTRUMENT 85601 CD STRAIGHT RED HK HLDR
MEDTRONIC SOFAMOR DANEK, INC.
85601
In Commercial Distribution

  • 00673978062297 ()


  • General-purpose surgical scissors, reusable
INSTRUMENT 84659 CD ILIO SAC SCRWDR CAN
MEDTRONIC SOFAMOR DANEK, INC.
84659
In Commercial Distribution

  • 00673978058238 ()


  • Orthopaedic implant driver
syngo Dynamics VA20F Workplace Installer CD Label
Siemens Healthcare GmbH
10745438
In Commercial Distribution

  • 04056869227047 ()


  • Radiological PACS software
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