FDA product code OAJ

Catheter, Drainage, Intraoral/Extraoral

General, Plastic Surgery·Class 1·21 CFR 878.4200
US regulatory classifications
US Product Code (FDA)
OAJ
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US Risk Class (FDA)
Class 1
US Regulation (CFR)
21 CFR 878.4200
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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

To allow continuous drainage of saliva and/or fluid irrigation of the salivary duct as well as assisting in maintaining duct patency during the healing process following removal of salivary gland stones for temporary insertion into the salivary gland, whether orally or through the cheek following endoscopic or surgical removal of salivary gland stones

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About this record

Catheter, Drainage, Intraoral/Extraoral 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.