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Sigma Lcs High Performance 9505-02-300

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 Number10603295228882 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  • Withdrawn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
Sigma Lcs High Performance
Generic Name
Fluted surgical drill bit, single-use
Model / Ref / Catalog
9505-02-300, 950502300
Primary DI / UDI-DI
10603295228882
FDA Product Code
LXH
GMDN Term
Fluted surgical drill bit, single-use
Device Class
Class I
Regulation Number
888.4540
GUDID distribution status
In Commercial Distribution

Related devices

Category: Fluted surgical drill bit, 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