Maxx-Cell 11GA X 11CM
Maxx-Cell 11GA X 11CM (MXC-1) is a Class II device made by Ranfac Corp., cleared under FDA 510(k) K150563 on 22 May 2015 and listed in FDA GUDID since 9 May 2018 (UDI-DI 00857878007354), 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 | Number00857878007354 | Date9 May 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK150563 | Date22 May 2015 | StatusActive |
Official records
- AccessGUDID record 00857878007354
- FDA 510(k) database K150563
Across registries
- FDA 510(k) K150563 decided 22 May 2015 Active
- FDA GUDID UDI-DI 00857878007354 listed 9 May 2018 Listed
Timeline
- Cleared FDA 510(k) K150563
- Listed FDA GUDID 00857878007354
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Maxx-Cell
- Generic name
- Bone access cannula
- Model / Ref / Catalog
- 11GA X 11CM, MXC-1
- Primary DI / UDI-DI
- 00857878007354
- 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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