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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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Free Prostate Specific Antigen Flex® reagent cartridge 80 Test
Siemens Healthcare Diagnostics Inc.
10445091
In Commercial Distribution

  • 00842768016677 ()
  • 00630414601786 ()
K6452

  • Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay
Total Prostate Specific Antigen Flex® reagent cartridge 120 Test
Siemens Healthcare Diagnostics Inc.
10445090
In Commercial Distribution

  • 00842768016660 ()
  • 00630414601779 ()
K6451

  • Total prostate specific antigen (tPSA) IVD, kit, chemiluminescent immunoassay
Heterogeneous Immunoassay Module Free Prostate Specific Antigen Flex® reagent cartridge 120 Test
Siemens Healthcare Diagnostics Inc.
10444888
In Commercial Distribution

  • 00842768013881 ()
  • 00630414601755 ()
RF452

  • Free (unbound) prostate specific antigen (fPSA) IVD, kit, enzyme immunoassay (EIA)
Heterogeneous Immunoassay Module Total/Free Prostate Specific Antigen Calibrator
Siemens Healthcare Diagnostics Inc.
10445031
In Commercial Distribution

  • 00842768013751 ()
RC452

  • Multiple-type clinical chemistry analyte profile IVD, calibrator
Barrier, Absorbable, Adhesion
GENZYME CORPORATION
4301-02
In Commercial Distribution

  • 00358468430120 ()
  • 30358468430121 ()

  • one 13 cm x 15 cm membrane/pouch
  • Area/Surface Area: 195 Square centimeter


  • Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated
Barrier, Absorbable, Adhesion
GENZYME CORPORATION
6642-01
In Commercial Distribution

  • 00358468664211 ()
  • 30358468664212 ()

  • two 7 cm x 13 cm membranes/pouch
  • Area/Surface Area: 195 Square centimeter


  • Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated
Barrier, Absorbable, Adhesion
GENZYME CORPORATION
6641-01
In Commercial Distribution

  • 00358468664112 ()
  • 30358468664113 ()

  • Area/Surface Area: 91 Square centimeter
  • one 7 cm x 13 cm membrane/pouch


  • Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated
Barrier, Absorbable, Adhesion
GENZYME CORPORATION
6380-01
In Commercial Distribution

  • 00358468638014 ()
  • 30358468638015 ()

  • Area/Surface Area: 195 Square centimeter
  • four 7.5 cm x 6.5 cm membranes/pouch


  • Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated
Barrier, Absorbable, Adhesion
GENZYME CORPORATION
5086-02
In Commercial Distribution

  • 00358468508621 ()
  • 30358468508622 ()

  • Area/Surface Area: 585 Square centimeter
  • six 7 cm x 13 cm membranes/pouch


  • Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated
Heterogeneous Immunoassay Module Total Prostate Specific Antigen Flex® reagent cartridge 120 Test
Siemens Healthcare Diagnostics Inc.
10444889
In Commercial Distribution

  • 00842768013874 ()
  • 00630414601762 ()
RF451

  • Total prostate specific antigen (tPSA) IVD, kit, enzyme immunoassay (EIA)
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