OEI
- Product code
- OEI
- Device name
- Drainage Catheter With Antibiotic
- Device class
- Class 2
- 21 CFR
- 21 CFR 878.4780
- Medical specialty
- General, Plastic Surgery
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 1
FDA classification 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.
Official FDA classification page: OEI
Classification and pathway per current FDA publications. Data from openFDA (CC0).