21 CFR 876.4560 — Ribdam
Gastroenterology, Urology (GU) · Subpart E—Surgical Devices · § 876.4560
Identification
A ribdam is a device that consists of a broad strip of latex with supporting ribs used to drain surgical wounds where copious urine drainage is expected.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| EYS | Ribdam | 1 | 0 |
