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Sonoma Orthopedic Products, Inc. 3.5mm Drill Bit Non-cannulated, Sterile

by Arthrex, Inc.

Listed FDA GUDID listing, not in commercial distribution

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00816988012399 UDI-DI Date6 Nov 2015ListedStatusListed GUDID: not 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  • Withdrawn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
Sonoma Orthopedic Products, Inc.
Generic Name
Fluted surgical drill bit, single-use, non-sterile
Model / Ref / Catalog
3.5mm Drill Bit Non-cannulated, Sterile, CS6135-S
Primary DI / UDI-DI
00816988012399
FDA Product Code
HTW
GMDN Term
Fluted surgical drill bit, single-use, non-sterile
Device Class
Class I
Regulation Number
888.4540
GUDID distribution status
Not in Commercial Distribution

Other devices from Arthrex, Inc.

See all devices from Arthrex, 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