Isis 520044
Isis 520044 is a Class II device made by inomed Medizintechnik GmbH, listed in FDA GUDID since 16 Sep 2022 (UDI-DI 04250307601981), registry data as of 23 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number04250307601981 | Date16 Sep 2022 | StatusListed |
Official records
- AccessGUDID record 04250307601981
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Isis
- Generic name
- Nerve-function monitor
- Model / reference
- 520044
- Primary DI / UDI-DI
- 04250307601981
- FDA product code
- GWF
- GMDN term
- Nerve-function monitor
- Device class
- Class II
- Regulation number
- 882.1870
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
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