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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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Patient-specific, Maxillofacial Surgical Guide
3D LIFEPRINTS UK LTD
CMFSG
In Commercial Distribution

  • 00860009815728 ()


  • Custom-made orthopaedic/craniofacial surgical guide
Patient-specific, Maxillofacial Anatomical Model, For End-user Sterilization
3D LIFEPRINTS UK LTD
CMFAMFEUS
In Commercial Distribution

  • 00860009815711 ()


  • Custom-made organ/bone anatomy model
Patient-specific, Maxillofacial Anatomical Model, Non-sterile
3D LIFEPRINTS UK LTD
CMFAMNS
In Commercial Distribution

  • 00860009815704 ()


  • Custom-made organ/bone anatomy model
Integrity Orthopaedics Anchor Array System Kit
Integrity Orthopaedics, Inc
901003
In Commercial Distribution

  • 00860009782228 ()
901003

  • Orthopaedic inorganic implant inserter/extractor, single-use
  • Tendon/ligament bone anchor, non-bioabsorbable
No Description
Aural Analytics, Inc.
SVCOG
Not in Commercial Distribution

  • 00860009693401 ()


  • Cognitive assessment software
Adult Airway Tape
KelCor, LLC
AWST-100001
In Commercial Distribution

  • 00860009651623 ()


  • Multi-purpose surgical skin adhesive tape
Adult Eye Tape
KelCor, LLC
EYST-300020
In Commercial Distribution

  • 00860009651616 ()


  • Eye patch
Short-term Adult Airway Tape and Eye Tape
KelCor, LLC
KTST-103001
In Commercial Distribution

  • 00860009651609 ()


  • Multi-purpose surgical skin adhesive tape
  • Eye patch
GAS, CALIBRATION (SPECIFIED CONCENTRATION) - Calibration Gas Mixture
Matheson Tri-Gas, Inc.
1
In Commercial Distribution

  • 00860009629530 ()


  • Multiple blood gas analyte IVD, calibrator
  • Blood gas analyser IVD, point-of-care
GAS, CALIBRATION (SPECIFIED CONCENTRATION) - Blood Gas Mixture
Matheson Tri-Gas, Inc.
1
In Commercial Distribution

  • 00860009629516 ()


  • Multiple blood gas analyte IVD, calibrator
  • Blood gas analyser IVD, point-of-care
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