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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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Intervertebral Body Fusion Device - 00840019923866

TLIF/ PLIF/ TPLIF system
PRECISION SPINE, INC.
21-1007 CA
In Commercial Distribution

  • 00840019923866 ()
21-1007 CA

  • Orthopaedic surgical procedure kit, non-medicated, reusable

IRISpec - 10837461002680

IRISPEC CA/CB/CC URINE CHEMISTRY CONTROLS
BECKMAN COULTER IRELAND INC.
CA/CB/CC URINE CHEMSITRY CONTROLS
In Commercial Distribution

  • 10837461002680 ()
800-7702

  • Multiple urine analyte IVD, control

IRISpec - 10837461002611

IRISPEC CA/CB/CC URINE CHEMISTRY CONTROLS
BECKMAN COULTER IRELAND INC.
CA/CB/CC URINE CHEMSITRY CONTROLS
In Commercial Distribution

  • 10837461002611 ()
800-7211

  • Multiple urine analyte IVD, control

Arthrex® - 00888867399372

Univers Revers CA Head & 155 Trials Case
ARTHREX, INC.
AR-9501H-CA155C
In Commercial Distribution

  • 00888867399372 ()
AR-9501H-CA155C

  • Device sterilization/disinfection container, reusable

OC-Auto - 00816917021706

Personal Use Kit OC-Auto, for Mather, CA
POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC
OCPU-VA1 213264
In Commercial Distribution

  • 00816917021706 ()


  • Faecal occult blood IVD, reagent

Curaplex - 00818834020893

TEE,AEROSOL,22MX22MX15F 50/BG 100/CA
TRI-ANIM HEALTH SERVICES, INC.
301-160EA
In Commercial Distribution

  • 00818834021432 ()
  • 00818834020893 ()
  • 00818834021975 ()
301-160EA

  • Oxygen administration tubing

VITROS - 10758750034901

VITROS Immunodiagnostic Products CA 125 II Calibrators
ORTHO CLINICAL DIAGNOSTICS
6177751
In Commercial Distribution

  • 10758750034901 ()
6177751

  • Cancer antigen 125 (CA125) IVD, kit, chemiluminescent immunoassay

VITROS - 10758750034833

VITROS Immunodiagnostic Products CA 19-9 Reagent Pack
ORTHO CLINICAL DIAGNOSTICS
6177747
In Commercial Distribution

  • 20758750034830 ()
  • 10758750034833 ()
6177747

  • Cancer antigen 19-9 (CA19-9) IVD, kit, chemiluminescent immunoassay

VITROS - 10758750002351

VITROS Immunodiagnostic Products CA 19-9 Reagent Pack
ORTHO CLINICAL DIAGNOSTICS
6802241
In Commercial Distribution

  • 10758750002351 ()
  • 20758750002358 ()
6802241

  • Cancer antigen 19-9 (CA19-9) IVD, kit, chemiluminescent immunoassay

VITROS - 10758750001323

VITROS Immunodiagnostic Products CA 15-3 Reagent Pack
ORTHO CLINICAL DIAGNOSTICS
6801758
In Commercial Distribution

  • 10758750001323 ()
  • 20758750001320 ()
6801758

  • Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay
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