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 55 Long x 5 Lead
Life Spine, Inc.
345-55-5
In Commercial Distribution

  • 00190837056780 ()
345-55-5

  • Bone-screw internal spinal fixation system, non-sterile
Nautilus Assembly CA, Ø4.5 x 50 Long x 5 Lead
Life Spine, Inc.
345-50-5
In Commercial Distribution

  • 00190837056773 ()
345-50-5

  • Bone-screw internal spinal fixation system, non-sterile
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
Series 1, 700 DT, Single CA, 1000mm, GEN2 4K CAM
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706009392 ()
C17S3W

  • Operating room light
Tricalcium silicate-based cement for contact with vital pulp and periradicular tissues. This cement is supplied as a powder and gel for mixing prior to use. Cement is radiopaque.
NUSMILE, LTD.
NMTA 7.0
Not in Commercial Distribution

  • 00862487000320 ()

  • Weight: 7.0 Gram
None

  • Glass ionomer dental cement
  • Endodontic filling/sealing material
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)
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
Biotyper system for clinical use in the USA, with smartbeam laser.
Bruker Daltonik GmbH
8604784
In Commercial Distribution

  • 04251204325734 ()
8604784

  • Microbial identification mass spectrometry system IVD
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