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Product code OAJ

Device name
Catheter, Drainage, Intraoral/Extraoral
Medical specialty
General, Plastic Surgery
Device class
1
Regulation number
878.4200
Review panel
DE
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
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
Source
FDA openFDA device classification dataset