Codman Certas® 828860
by Integra LifeSciences Production Corporation
Codman Certas® 828860 (82-8860) is a Class II device made by Integra LifeSciences Production Corporation, cleared under FDA 510(k) K143111 on 19 Feb 2015 and listed in FDA GUDID since 28 Feb 2020 (UDI-DI 10381780521341), 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 | Number10381780521341 | Date28 Feb 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK143111 | Date19 Feb 2015 | StatusActive |
Official records
- AccessGUDID record 10381780521341
- FDA 510(k) database K143111
Across registries
- FDA 510(k) K143111 decided 19 Feb 2015 Active
- FDA GUDID UDI-DI 10381780521341 listed 28 Feb 2020 Listed
Timeline
- Cleared FDA 510(k) K143111
- Listed FDA GUDID 10381780521341
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Codman Certas®
- Generic name
- Cerebrospinal fluid shunt valve programmer
- Model / Ref / Catalog
- 828860, 82-8860
- Primary DI / UDI-DI
- 10381780521341
- 510(k) Number
- FDA product code
- JXG
- GMDN term
- Cerebrospinal fluid shunt valve programmer
- Device class
- Class II
- Regulation number
- 882.5550
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
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