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Kaye Products - R3BSX

by Kaye Products, 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 1 Jun 2026. What this means

Regulatory status

as of registry sync 1 Jun 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00810117140632 UDI-DI Date5 Jul 2023ListedStatusListed 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  • Withdrawn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

Generic Name
Handgrip disability-assistive walker, non-powered, foldable
Model / Reference
R3BSX
Primary DI / UDI-DI
00810117140632
FDA Product Code
ITJ
GMDN Term
Handgrip disability-assistive walker, non-powered, foldable
Device Class
Class I
Regulation Number
890.3825
GUDID distribution status
Not in Commercial Distribution

Other devices from Kaye Products, Inc.

See all devices from Kaye Products, Inc. →

Properties

  • Over-the-Counter
  • Premarket Exempt

Other properties (12)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No