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SurgiTel EVC300 FLM

by Surgitel

SurgiTel EVC300 FLM is a Class I device made by Surgitel, listed in FDA GUDID since 12 Jan 2023 (UDI-DI 00810114910030), registry data as of 22 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00810114910030 UDI-DI Date12 Jan 2023ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
SurgiTel
Generic name
Surgical binoculars, reusable
Model / reference
EVC300 FLM
Primary DI / UDI-DI
00810114910030
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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Properties

  • Premarket exempt
Other properties (14, all answered No)