Barrier Bb-0528X
Barrier Bb-0528X (BB-0528X-1) is a Class I device made by Certol International, LLC, cleared under FDA 510(k) K922175 on 6 Aug 1992 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI H816BB0528X1), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberH816BB0528X1 | Date23 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK922175 | Date6 Aug 1992 | StatusActive |
Official records
- FDA 510(k) database K922175
Across registries
- FDA 510(k) K922175 decided 6 Aug 1992 Active
- FDA GUDID UDI-DI H816BB0528X1 listed 23 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K922175
- Listed FDA GUDID H816BB0528X1
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Barrier
- Generic name
- Instrument/equipment drape, single-use, non-sterile
- Model / Ref / Catalog
- BB-0528X, BB-0528X-1
- Primary DI / UDI-DI
- H816BB0528X1
- 510(k) Number
- FDA product code
- KLC
- GMDN term
- Instrument/equipment drape, single-use, non-sterile
- Device class
- Class I
- Regulation number
- 872.6250
- GUDID distribution status
- In Commercial Distribution
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