FDA product code ODY

Tunneled Catheter Remover

General Hospital·Class 2·21 CFR 880.5970
US regulatory classifications
US Product Code (FDA)
ODY
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 880.5970
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Medical specialty
General Hospital
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
Definition

To assist in the removal of tunneled long term catheter cuffs using a minimal invasive technique by seperating the tissue ingrowth cuff from the surrounding tissue. Following seperation of the cuff from the tissue, the catheter can be safely removed from the body.

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About this record

Tunneled Catheter Remover is a medical device type in the General Hospital specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.