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Long Threaded 2.8mm Guide Pin GPT-001-SP

by Curvafix 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 Number10850070500088 UDI-DI Date23 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  • Withdrawn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
Long Threaded 2.8mm Guide Pin
Generic Name
Orthopaedic guidewire, single-use
Model / Ref / Catalog
GPT-001-SP
Primary DI / UDI-DI
10850070500088
FDA Product Code
LXH
GMDN Term
Orthopaedic guidewire, single-use
Device Class
Class I
Regulation Number
888.4540
GUDID distribution status
In Commercial Distribution
Size
Length — 455 Millimeter

Other devices from Curvafix Inc

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Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (8)

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