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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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TendoNova Ocelot - 00860009899865

TendoNova Disposable Unit 60mm Kit-Single
Tendonova Corporation
DU1F60L-K
In Commercial Distribution

  • 00860009899865 ()

  • Length: 60 Millimeter


  • Skin topical coupling gel
  • Soft-tissue ultrasonic surgical system handpiece tip, single-use
  • Skin-cover adhesive strip, non-antimicrobial
  • Patient surgical drape, single-use
  • Orthopaedic implant aiming arm

TendoNova Ocelot - 00860009899858

TendoNova Disposable Unit 80mm Kit-Single
Tendonova Corporation
DU1F80L-K
In Commercial Distribution

  • 00860009899858 ()

  • Length: 80 Millimeter


  • Soft-tissue ultrasonic surgical system handpiece tip, single-use
  • Spiral blade
  • Skin topical coupling gel
  • Skin-cover adhesive strip, non-antimicrobial
  • Patient surgical drape, single-use

TendoNova Ocelot - 00860009899841

TendoNova Disposable Unit 60mm Kit
Tendonova Corporation
DU5F60L-K
In Commercial Distribution

  • 00860009899841 ()

  • Length: 60 Millimeter


  • Soft-tissue ultrasonic surgical system handpiece tip, single-use
  • Skin topical coupling gel
  • Skin-cover adhesive strip, non-antimicrobial
  • Patient surgical drape, single-use

kidneyintelX.dkd Single Tube Specimen Collection KIt - 00860009877931

Collection convenience kit to collect, contain, and ship a single human blood specimen to a Renalytix laboratory for kidneyintelX.dkd testing
Renalytix Ai, Inc.
RENX-3011087
In Commercial Distribution

  • 00860009877931 ()


  • General specimen collection kit

kidneyintelX.dkd Test - 00860009877924

Test Report for the kidneyintelX.dkd test.
Renalytix Ai, Inc.
1
In Commercial Distribution

  • 00860009877924 ()


  • Kidney disease progression risk assessment interpretive software IVD
  • Multiple chronic kidney disease (CKD) marker IVD, kit, chemiluminescent immunoassay

RenalytixAI Urine Collection Kit - 00860009877917

Collection kit used to collect, contain and ship human urine to a Renalytix clinical laboratory for uACR testing
Renalytix Ai, Inc.
RENX3011003
In Commercial Distribution

  • 00860009877917 ()


  • General specimen collection kit

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
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