LEYLA Retractor Socket 01
LEYLA Retractor Socket 01 (113243) is a Class II device made by NORAS MRI products GmbH, cleared under FDA 510(k) K133506 on 6 Aug 2014 (1 earlier submission) and listed in FDA GUDID since 6 Sep 2017 (UDI-DI 04251269201103), 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 | Number04251269201103 | Date6 Sep 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK133506 | Date6 Aug 2014 | StatusActive |
Official records
- AccessGUDID record 04251269201103
- FDA 510(k) database K133506
- FDA 510(k) database K071179
Across registries
- FDA 510(k) K133506 decided 6 Aug 2014 Active
- FDA GUDID UDI-DI 04251269201103 listed 6 Sep 2017 Listed
Timeline
- Cleared FDA 510(k) K071179
- Cleared FDA 510(k) K133506
- Listed FDA GUDID 04251269201103
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- LEYLA Retractor Socket
- Generic name
- MRI system coil, radio-frequency
- Model / Ref / Catalog
- 01, 113243
- Primary DI / UDI-DI
- 04251269201103
- FDA product code
- MOS
- GMDN term
- MRI system coil, radio-frequency
- Device class
- Class II
- Regulation number
- 892.1000
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Safe
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