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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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Nautilus Polyaxial Screw CA, 8.5mm x 60mm Cannulated
Life Spine, Inc.
1385-60-5
In Commercial Distribution

  • 00190837053932 ()
1385-60-5

  • Spinal bone screw, non-bioabsorbable
EASY MOUNTER PRAMA CA, POST EXTRACT, SLEEVE 550
SWEDEN & MARTINA SPA
GS-EASYPE-L-550-CA
In Commercial Distribution

  • D7701515633 ()
GS-EASYPE-L-550-CA

  • Surgical screwdriver, reusable
EASY MOUNTER PRAMA CA, POST EXTRACT, SLEEVE 415
SWEDEN & MARTINA SPA
GS-EASYPE-L-415-CA
In Commercial Distribution

  • D7701515623 ()
GS-EASYPE-L-415-CA

  • Surgical screwdriver, reusable
VITROS Immunodiagnostic Products CA 125 II Reagent Pack
ORTHO CLINICAL DIAGNOSTICS
6177746
In Commercial Distribution

  • 10758750034826 ()
6177746

  • Cancer antigen 125 (CA125) IVD, kit, chemiluminescent immunoassay
VITROS Immunodiagnostic Products CA 19-9™ Range Verifiers
ORTHO CLINICAL DIAGNOSTICS
6802242
In Commercial Distribution

  • 10758750002368 ()
  • 20758750002365 ()
6802242

  • Cancer antigen 19-9 (CA19-9) IVD, kit, chemiluminescent immunoassay
VITROS Immunodiagnostic Products CA 125 II Reagent Pack
ORTHO CLINICAL DIAGNOSTICS
6801757
In Commercial Distribution

  • 10758750001316 ()
6801757

  • Cancer antigen 125 (CA125) IVD, kit, chemiluminescent immunoassay
VITROS Immunodiagnostic Products CA 15-3™ Range Verifiers
ORTHO CLINICAL DIAGNOSTICS
6800879
In Commercial Distribution

  • 10758750000999 ()
  • 20758750000996 ()
6800879

  • Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay
Bone Screws, and Central Cancellous Bone Screw, Ca
WALDEMAR LINK GmbH & Co. KG
645-070/40
In Commercial Distribution

  • 04026575240494 ()
645-070/40

  • Orthopaedic bone screw (non-sliding)
Bone Screws, and Central Cancellous Bone Screw, Ca
WALDEMAR LINK GmbH & Co. KG
645-070/35
In Commercial Distribution

  • 04026575240487 ()
645-070/35

  • Orthopaedic bone screw (non-sliding)
Bone Screws, and Central Cancellous Bone Screw, Ca
WALDEMAR LINK GmbH & Co. KG
645-070/30
In Commercial Distribution

  • 04026575240470 ()
645-070/30

  • Orthopaedic bone screw (non-sliding)
Bone Screws, and Central Cancellous Bone Screw, Ca
WALDEMAR LINK GmbH & Co. KG
645-070/25
In Commercial Distribution

  • 04026575240463 ()
645-070/25

  • Orthopaedic bone screw (non-sliding)
Bone Screws, and Central Cancellous Bone Screw, Ca
WALDEMAR LINK GmbH & Co. KG
645-070/20
In Commercial Distribution

  • 04026575240456 ()
645-070/20

  • Orthopaedic bone screw (non-sliding)
Personal Use Kit OC-Auto, for VA Livermore, CA
POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC
OCPU-VA1 918369
In Commercial Distribution

  • 00816917026107 ()


  • Faecal occult blood IVD, reagent
Personal Use Kit OC-Auto, for San Diego, CA
POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC
OCPU-VA1 2334351
In Commercial Distribution

  • 00816917022024 ()


  • Faecal occult blood IVD, reagent
Personal Use Kit OC-Auto, for Palo Alto, CA
POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC
OCPU-VA1 2334272
In Commercial Distribution

  • 00816917021973 ()


  • Faecal occult blood IVD, reagent
Personal Use Kit OC-Auto, for Loma Linda, CA
POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC
OCPU-VA1 2333714
In Commercial Distribution

  • 00816917021898 ()


  • Faecal occult blood IVD, reagent
Personal Use Kit OC-Auto, for Long Beach, CA
POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC
OCPU-VA1 220104
In Commercial Distribution

  • 00816917021713 ()


  • Faecal occult blood IVD, reagent
Personal Use Kit OC-Auto, for West LA, CA
POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC
OCPU-VA1 213230
In Commercial Distribution

  • 00816917021416 ()


  • Faecal occult blood IVD, reagent
Personal Use Kit OC-Auto, for Univ CA Urvine
POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC
OCPU-UCI
In Commercial Distribution

  • 00816917021317 ()


  • Faecal occult blood IVD, reagent
VELOCITY SLB CA MBT ANT -6T 0A .018
LANCER ORTHODONTICS, INC.
24M-58U
In Commercial Distribution

  • 00817573025077 ()


  • Orthodontic bracket, metal
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