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 Assembly CA, Ø4.5 x 45 Long x 5 Lead
Life Spine, Inc.
345-45-5
In Commercial Distribution

  • 00190837056766 ()
345-45-5

  • Bone-screw internal spinal fixation system, non-sterile
Nautilus Assembly CA, Ø4.5 x 40 Long x 5 Lead
Life Spine, Inc.
345-40-5
In Commercial Distribution

  • 00190837056759 ()
345-40-5

  • Bone-screw internal spinal fixation system, non-sterile
OC-Auto SENSOR io Personal Use Kit for VA Mather, CA
POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC
OCPUIO-VA1 213264
In Commercial Distribution

  • 00816917026756 ()


  • Faecal occult blood IVD, reagent
Series 1, 700 DT, Single CA, 1000mm, GEN2 4K CAM
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706009392 ()
C17S3W

  • Operating room light
For coagulation tests and as a rinsing solution for the sample needles of the Sysmex® CA Systems
Siemens Healthcare Diagnostics Products GmbH
10873915
In Commercial Distribution

  • 00842768019845 ()
  • 00630414639901 ()
10873915

  • Buffered sample diluent IVD
No Description
TOSOH CORPORATION
N/A
In Commercial Distribution

  • 14560189210216 ()
  • 04560189210219 ()


  • Cancer antigen 125 (CA125) IVD, kit, enzyme immunoassay (EIA)
No Description
TOSOH CORPORATION
N/A
In Commercial Distribution

  • 14560189210209 ()
  • 04560189210202 ()


  • Cancer antigen 19-9 (CA19-9) IVD, kit, enzyme immunoassay (EIA)
No Description
Roche Diagnostics GmbH
09755594190
In Commercial Distribution

  • 07613336218334 ()
09755594190

  • Cancer antigen 15-3 (CA15-3) IVD, kit, enzyme immunoassay (EIA)
No Description
Roche Diagnostics GmbH
09755586190
In Commercial Distribution

  • 07613336218327 ()
09755586190

  • Cancer antigen 125 (CA125) IVD, kit, chemiluminescent immunoassay
No Description
Roche Diagnostics GmbH
07027001190
In Commercial Distribution

  • 04015630939961 ()
07027001190

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