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Monoblock Ball Stem Impactor 112-25-0181

by Signature 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 Number09348215088293 UDI-DI Date11 Feb 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  • Withdrawn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

Trade Name
Monoblock Ball Stem Impactor
Generic Name
Orthopaedic implant impactor, reusable
Model / Reference
112-25-0181
Primary DI / UDI-DI
09348215088293
FDA Product Code
LXH
GMDN Term
Orthopaedic implant impactor, reusable
Device Class
Class I
Regulation Number
888.4540
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Category: Orthopaedic implant impactor, reusable

Other devices from Signature Orthopaedics Pty Ltd

See all devices from Signature Orthopaedics Pty Ltd →

Properties

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

Other properties (10)

  • Sterile: No
  • Single Use: 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