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Specialist 97-6748

by Depuy Orthopaedics, 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 Number10603295251460 UDI-DI Date24 Sep 2018ListedStatusListed 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  • Withdrawn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
Specialist
Generic Name
Orthopaedic prosthesis implantation positioning instrument, single-use
Model / Ref / Catalog
97-6748, 976748
Primary DI / UDI-DI
10603295251460
FDA Product Code
HWE
GMDN Term
Orthopaedic prosthesis implantation positioning instrument, single-use
Device Class
Class I
Regulation Number
878.4820
GUDID distribution status
In Commercial Distribution

Related devices

Category: Orthopaedic prosthesis implantation positioning instrument, single-use

Other devices from Depuy Orthopaedics, Inc.

See all devices from Depuy Orthopaedics, Inc. →

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