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Griplasty System GPIs

by Field Orthopaedics Pty Ltd

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 Number09353903030218 UDI-DI Date24 Jun 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  • Withdrawn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
Griplasty System
Generic Name
Cannulated surgical drill bit, single-use
Model / Ref / Catalog
GPIs
Primary DI / UDI-DI
09353903030218
FDA Product Code
HTW, HTY, LXH
GMDN Term
Cannulated surgical drill bit, single-use
Device Class
Class I
Regulation Number
888.4540, 888.3040
GUDID distribution status
In Commercial Distribution

Other devices from Field Orthopaedics Pty Ltd

See all devices from Field Orthopaedics Pty Ltd →

Properties

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

Other properties (9)

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