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Elmed Incorporated ST33694-01

by Elmed Incorporated

Elmed Incorporated ST33694-01 is a Class I device made by Elmed Incorporated, listed in FDA GUDID since 9 Oct 2026 (UDI-DI 00198506095870), 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 Number00198506095870 UDI-DI Date9 Oct 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  • Withdrawn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
Elmed Incorporated
Generic name
Orthopaedic osteotome
Model / Ref / Catalog
ST33694-01
Primary DI / UDI-DI
00198506095870
FDA product code
FZY
GMDN term
Orthopaedic osteotome
Device class
Class I
Regulation number
878.4800
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Other devices from Elmed Incorporated

See all devices from Elmed Incorporated →

Properties

  • Sterilise before use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (10, all answered No)