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EF1 916-07-0001

by Medshape, Inc.

EF1 916-07-0001 is a Class I device made by Medshape, Inc., listed in FDA GUDID since 25 Jun 2026 (UDI-DI 00190446907466), registry data as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00190446907466 UDI-DI Date25 Jun 2026ListedStatusListed 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  • Withdrawn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
EF1
Generic name
Instrument tray, reusable
Model / reference
916-07-0001
Primary DI / UDI-DI
00190446907466
FDA product code
FSM
GMDN term
Instrument tray, reusable
Device class
Class I
Regulation number
878.4800
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Similar devices

Other devices filed under FDA product code FSM (TRAY, SURGICAL, INSTRUMENT).

Other devices from Medshape, Inc.

See all devices from Medshape, Inc. →

Properties

  • Sterilise before use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (11, all answered No)