Luke Replaceable Part LU-60101-300
Luke Replaceable Part LU-60101-300 is a device of GMDN type myoelectric hand prosthesis (FDA Class II; FDA product code PAE) made by Mobius Bionics LLC, granted FDA De Novo DEN120016 on 9 May 2014 and listed in FDA GUDID since 21 Oct 2016 (UDI-DI 00859503006541), active as of 22 Oct 2026.
Active
De Novo
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00859503006541 | Date21 Oct 2016 | StatusListed |
| United States | FDA De NovoDENG | NumberDEN120016 | Date9 May 2014 | StatusActive |
Official records
- AccessGUDID record 00859503006541
- FDA De Novo database DEN120016
Across registries
- FDA De Novo DEN120016 decided 9 May 2014 Active
- FDA GUDID UDI-DI 00859503006541 listed 21 Oct 2016 Listed
Timeline
- Granted FDA De Novo DEN120016
- Listed FDA GUDID 00859503006541
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA De Novo Active
Specification
- Trade name
- Luke Replaceable Part
- Generic name
- Myoelectric hand prosthesis
- Model / reference
- LU-60101-300
- Primary DI / UDI-DI
- 00859503006541
- De Novo Number
- FDA product code
- PAE
- GMDN term
- Myoelectric hand prosthesis
- Device class
- Class II
- Regulation number
- 890.3450
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe