Medbone MB13150-10
Medbone MB13150-10 is a Class II device made by Medax Unipersonale Srl, cleared under FDA 510(k) K172344 on 13 Nov 2017 and listed in FDA GUDID since 10 Apr 2018 (UDI-DI 08056772675931), 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 | Number08056772675931 | Date10 Apr 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK172344 | Date13 Nov 2017 | StatusActive |
Official records
- AccessGUDID record 08056772675931
- FDA 510(k) database K172344
Across registries
- FDA 510(k) K172344 decided 13 Nov 2017 Active
- FDA GUDID UDI-DI 08056772675931 listed 10 Apr 2018 Listed
Timeline
- Cleared FDA 510(k) K172344
- Listed FDA GUDID 08056772675931
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Medbone
- Generic name
- Bone marrow biopsy needle, single-use
- Model / reference
- MB13150-10
- Primary DI / UDI-DI
- 08056772675931
- 510(k) Number
- FDA product code
- KNW
- GMDN term
- Bone marrow biopsy needle, single-use
- Device class
- Class II
- Regulation number
- 876.1075
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
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