Braincare BcSs-PICNI-2000
by Braincare Desenvolvimento E Inovacao Tecnologica SA
Braincare BcSs-PICNI-2000 is a Class II device made by Braincare Desenvolvimento E Inovacao Tecnologica SA, cleared under FDA 510(k) K182073 on 17 Oct 2019 and listed in FDA GUDID since 8 May 2026 (UDI-DI 07908398200008), 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 | Number07908398200008 | Date8 May 2026 | StatusListed |
| United States | FDA 510(k)SESE | NumberK182073 | Date17 Oct 2019 | StatusActive |
Official records
- AccessGUDID record 07908398200008
- FDA 510(k) database K182073
Across registries
- FDA 510(k) K182073 decided 17 Oct 2019 Active
- FDA GUDID UDI-DI 07908398200008 listed 8 May 2026 Listed
Timeline
- Cleared FDA 510(k) K182073
- Listed FDA GUDID 07908398200008
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Braincare
- Generic name
- Intracranial pressure monitor
- Model / reference
- BcSs-PICNI-2000
- Primary DI / UDI-DI
- 07908398200008
- 510(k) Number
- FDA product code
- GWM
- GMDN term
- Intracranial pressure monitor
- Device class
- Class II
- Regulation number
- 882.1620
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
- Size
- Length — 70 MillimeterWidth — 20 MillimeterHeight — 40 Millimeter
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