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N/A 145613

by Tetra Medical Supply Corp.

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 Number00614138127364 UDI-DI Date30 Jul 2022ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Generic Name
Wrist orthosis
Model / Ref / Catalog
145613
Primary DI / UDI-DI
00614138127364
FDA Product Code
ILH
GMDN Term
Wrist orthosis
Device Class
Class I
Regulation Number
890.3475
GUDID distribution status
In Commercial Distribution

Related devices

Category: Wrist orthosis

Other devices from Tetra Medical Supply Corp.

See all devices from Tetra Medical Supply Corp. →

Properties

  • Over-the-Counter
  • Premarket Exempt

Other properties (12)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No