FDA product code OEI

Drainage Catheter With Antibiotic

General, Plastic Surgery·Class 2·21 CFR 878.4780
US regulatory classifications
US Product Code (FDA)
OEI
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 878.4780
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Medical specialty
General, Plastic Surgery
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
Definition

A tubular drain made from silicone or similar material and is coated with a silver containing material and is intended to drain fluids from body cavities using gravity drainage or attached to a suction pump.

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About this record

Drainage Catheter With Antibiotic is a medical device type in the General, Plastic Surgery 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.