Sigma 350-201-35
Sigma 350-201-35 is a Class I device made by Alphatec Spine, Inc., listed in FDA GUDID since 8 Jan 2023 (UDI-DI 00190376471563), 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 | Number00190376471563 | Date8 Jan 2023 | StatusListed |
Official records
- AccessGUDID record 00190376471563
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Sigma
- Generic name
- Surgical retraction system, reusable
- Model / reference
- 350-201-35
- Primary DI / UDI-DI
- 00190376471563
- FDA product code
- GAD
- GMDN term
- Surgical retraction system, reusable
- Device class
- Class I
- Regulation number
- 878.4800
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
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