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MARK3® 5974

by Cargus International, Inc

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 Number00850014374990 UDI-DI Date5 Feb 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  • Withdrawn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
MARK3®
Generic name
Root canal cleaning solution
Model / Ref / Catalog
5974
Primary DI / UDI-DI
00850014374990
FDA product code
EIC
GMDN term
Root canal cleaning solution
Device class
Class I
Regulation number
872.4565
GUDID distribution status
In Commercial Distribution

Other devices from Cargus International, Inc

See all devices from Cargus International, Inc →

Properties

  • Premarket exempt
  • Lot / batch number
  • Expiration date

Other properties (12)

  • Supplied sterile: No
  • Sterilise before use: 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
  • Serial number: No
  • Manufacturing date: No