SurgiTel EVK800 FLM
by Surgitel
SurgiTel EVK800 FLM is a Class I device made by Surgitel, listed in FDA GUDID since 12 Jan 2023 (UDI-DI 00810114910184), registry data as of 22 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 | Number00810114910184 | Date12 Jan 2023 | StatusListed |
Official records
- AccessGUDID record 00810114910184
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- SurgiTel
- Generic name
- Surgical binoculars, reusable
- Model / reference
- EVK800 FLM
- Primary DI / UDI-DI
- 00810114910184
- FDA product code
- HOH
- GMDN term
- Surgical binoculars, reusable
- Device class
- Class I
- Regulation number
- 886.4770
- GUDID distribution status
- In Commercial Distribution
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