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3M™ Unitek™ Orthodontic Hand Instruments 804--161

by 3M Unitek Corporation

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

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00652221110138 UDI-DI Date7 May 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
3M™ Unitek™ Orthodontic Hand Instruments
Generic Name
Orthodontic pliers
Model / Ref / Catalog
804--161
Primary DI / UDI-DI
00652221110138
FDA Product Code
JEX
GMDN Term
Orthodontic pliers
Device Class
Class I
Regulation Number
872.4565
GUDID distribution status
In Commercial Distribution

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Properties

  • Single Use
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (9)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No