Emphasys 4742-08-200
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number10603295505587 | Date28 Aug 2021 | StatusListed |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Emphasys
- Generic name
- Coated femoral stem prosthesis, one-piece
- Model / Ref / Catalog
- 4742-08-200, 474208200
- Primary DI / UDI-DI
- 10603295505587
- FDA product code
- LZO, KWL, KWY, MEH
- GMDN term
- Coated femoral stem prosthesis, one-piece
- Device class
- Class II
- Regulation number
- 888.3353, 888.3360, 888.3390
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Conditional
Other devices from Depuy (Ireland)
Properties
Other properties (9)
- Sterilise before use: No
- Contains latex: No
- Over-the-counter: No
- Convenience kit: No
- Combination product: No
- HCT/P: No
- Premarket exempt: No
- Serial number: No
- Manufacturing date: No