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Ortho Solutions Sterile Drill Bits OS200025

by Ortho Solutions Holdings Limited

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

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 Number05055662930788 UDI-DI Date20 Jan 2017ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Ortho Solutions Sterile Drill Bits
Generic Name
Fluted surgical drill bit, single-use, non-sterile
Model / Ref / Catalog
OS200025
Primary DI / UDI-DI
05055662930788
510(k) Number
FDA Product Code
HWE
GMDN Term
Fluted surgical drill bit, single-use, non-sterile
Device Class
Class I
Regulation Number
878.4820
GUDID distribution status
In Commercial Distribution

Related devices

Category: Fluted surgical drill bit, single-use, non-sterile

Cleared under the same submission (K102743)

Show all (12)

Other devices from Ortho Solutions Holdings Limited

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Properties

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

Other properties (10)

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