21 CFR §876.4560
Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
- (a)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.
- (b)Classification. 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.