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Identity CR KA 5253-0001

by Restor3D

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 Number00840097536705 UDI-DI Date25 Sep 2026ListedStatusListed 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  • Withdrawn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
Identity CR KA
Generic Name
Total knee prosthesis implantation guide-instrument kit
Model / Ref / Catalog
5253-0001, TCR-000- D001
Primary DI / UDI-DI
00840097536705
FDA Product Code
JWH, OIY, OOG
GMDN Term
Total knee prosthesis implantation guide-instrument kit
Device Class
Class II
Regulation Number
888.3560
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Conditional

Other devices from Restor3D

See all devices from Restor3D →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Convenience Kit
  • Serial Number
  • Expiration Date

Other properties (8)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Manufacturing Date: No