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TruFit™ 493-12-2631-315-3

by Ortho Organizers, Inc.

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00190707166809 UDI-DI Date9 Oct 2025ListedStatusListed 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  • Withdrawn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
TruFit™
Generic Name
Orthodontic metal band
Model / Reference
493-12-2631-315-3
Primary DI / UDI-DI
00190707166809
FDA Product Code
ECM
GMDN Term
Orthodontic metal band
Device Class
Class I
Regulation Number
872.5410
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Other devices from Ortho Organizers, Inc.

See all devices from Ortho Organizers, Inc. →

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