Ran-11B 11GA X 11cm
Ran-11B 11GA X 11cm is a Class II device made by Ranfac Corp., cleared under FDA 510(k) K131157 on 22 Oct 2013 and listed in FDA GUDID since 7 Jan 2022 (UDI-DI 00850023741592), active as of 22 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 | Number00850023741592 | Date7 Jan 2022 | StatusListed |
| United States | FDA 510(k) | NumberK131157 | Date22 Oct 2013 | StatusActive |
Official records
- AccessGUDID record 00850023741592
- FDA 510(k) database K131157
Across registries
- FDA 510(k) K131157 decided 22 Oct 2013 Active
- FDA GUDID UDI-DI 00850023741592 listed 7 Jan 2022 Listed
Timeline
- Cleared FDA 510(k) K131157
- Listed FDA GUDID 00850023741592
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Ran-11B
- Generic name
- Bone access cannula
- Model / Ref / Catalog
- 11GA X 11CM, RAN-11B
- Description
- RAN-11B PN: 74406-01M
- Primary DI / UDI-DI
- 00850023741592
- 510(k) Number
- FDA product code
- KNW
- GMDN term
- Bone access cannula
- Device class
- Class II
- Regulation number
- 876.1075
- GUDID distribution status
- In Commercial Distribution
- Size
- Length — 11 CentimeterNeedle Gauge — 11 Gauge
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