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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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KidneyIntelX Blood Collection Convenience Kit - 00860009877900

Collection convenience kit used to collect, contain and ship human blood to a Renalytix clinical laboratory for KidneyIntelX testing.
Renalytix Ai, Inc.
RENX-3011000
In Commercial Distribution

  • 00860009877900 ()


  • General specimen collection kit

Clearwand - 00860009877801

Rectal Cleansing System
MORRIS MEDICAL, INC.
CW1000
In Commercial Distribution

  • 00860009877818 ()
  • 00860009877801 ()


  • Surgical irrigation/aspiration tubing set

Butterfly Needle Phlebotomy Kit - 00860009842281

No Description
Labcorp Genetics Inc
K-INV-PHLEBOTOMY-BN/000
In Commercial Distribution

  • 00860009842281 ()


  • Blood collection set, invasive

RNA + Hereditary Cancer Blood Collection Kit - 00860009842267

No Description
Labcorp Genetics Inc
K-INV-RNA / 000
In Commercial Distribution

  • 00860009842267 ()


  • General specimen collection kit IVD, clinical

Non-Invasive Prenatal Screening (NIPS) + Carrier Screening Collection Kit - 00860009842236

No Description
Labcorp Genetics Inc
K-INV-N-CARRIER / 000
Not in Commercial Distribution

  • 00860009842236 ()
K-INV-N-CARRIER / 000

  • General specimen collection kit IVD, clinical

Videa Perio Assist - 00860009836815

Videa Perio Assist is a radiological semi-automated image processing software device intended to aid dental professionals in the measurements and visualization of mesial and distal bone levels associated with each tooth from bitewing and periapical radiographs. Measurements are made available as linear distances or relative percentages.
Videahealth, Inc.
VPA01BP
In Commercial Distribution

  • 00860009836815 ()


  • Dental x-ray image interpretive software

EmbedMed - 00860009815773

Patient-specific, Orthopedic Anatomical Model, Non-sterile
3D LIFEPRINTS UK LTD
OTHAMNS
In Commercial Distribution

  • 00860009815773 ()


  • Custom-made organ/bone anatomy model

EmbedMed - 00860009815766

Patient-specific, Orthopedic Anatomical Model, For End-user Sterilization
3D LIFEPRINTS UK LTD
OTHAMFEUS
In Commercial Distribution

  • 00860009815766 ()


  • Custom-made organ/bone anatomy model

EmbedMed - 00860009815742

Patient-specific, Othopedic Anatomical Model, Digital
3D LIFEPRINTS UK LTD
OTHDAM
Not in Commercial Distribution

  • 00860009815742 ()


  • Custom-made organ/bone anatomy model

EmbedMed - 00860009815735

Patient-specific, Maxillofacial Anatomical Model, Digital
3D LIFEPRINTS UK LTD
CMFDAM
Not in Commercial Distribution

  • 00860009815735 ()


  • Custom-made organ/bone anatomy model
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