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Restore IQ System R-A1016-FR2-40

by Restore Medical Solutions, Inc.

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 Number00860190001443 UDI-DI Date23 Feb 2018ListedStatusListed 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  • Withdrawn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
Restore IQ System
Generic Name
Device sterilization/disinfection container, reusable
Model / Reference
R-A1016-FR2-40
Primary DI / UDI-DI
00860190001443
510(k) Number
FDA Product Code
KCT
GMDN Term
Device sterilization/disinfection container, reusable
Device Class
Class II
Regulation Number
880.6850
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Category: Device sterilization/disinfection container, reusable

Cleared under the same submission (K131455)

Show all (9)

Other devices from Restore Medical Solutions, Inc.

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Properties

  • Lot / Batch Number

Other properties (13)

  • Sterile: No
  • Single Use: No
  • 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
  • Expiration Date: No
  • Manufacturing Date: No