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ArthroFree® 2 Operating Room Kit AF0116-101

by Lazurite Holdings LLC

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 Number00850045863036 UDI-DI Date10 Jul 2026ListedStatusListed 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  • Withdrawn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
ArthroFree® 2 Operating Room Kit
Generic Name
Video camera surgical microscope system
Model / Ref / Catalog
AF0116-101, ARTH-0006
Primary DI / UDI-DI
00850045863036
510(k) Number
FDA Product Code
GCJ
GMDN Term
Video camera surgical microscope system
Device Class
Class II
Regulation Number
876.1500
GUDID distribution status
In Commercial Distribution
Sterilization Method
Hydrogen Peroxide

Related devices

Cleared under the same submission (K213860)

Other devices from Lazurite Holdings LLC

See all devices from Lazurite Holdings LLC →

Properties

  • Prescription Use
  • Lot / Batch Number
  • Serial 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
  • Premarket Exempt: No
  • Expiration Date: No