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Trigen E0016377-1

by Smith & Nephew, Inc.

Trigen E0016377-1 is a Class I device made by Smith & Nephew, Inc., listed in FDA GUDID since 13 Feb 2019 (UDI-DI 00885556739655), 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 Number00885556739655 UDI-DI Date13 Feb 2019ListedStatusListed 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  • Withdrawn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
Trigen
Generic name
Surgical depth gauge, reusable
Model / Ref / Catalog
E0016377-1
Primary DI / UDI-DI
00885556739655
FDA product code
FTY
GMDN term
Surgical depth gauge, 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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Properties

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