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MARK3 6117

by Cargus International, Inc 2 variants

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberD796611705 UDI-DI Date8 Jul 2019ListedStatusListed 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  • Withdrawn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
Sterilization container liner
Model / reference
6117
Primary DI / UDI-DI
D796611705
FDA product code
FRG, JOJ
GMDN term
Sterilization container liner
Device class
Class II
Regulation number
880.6850, 880.2800
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Sterilization container liner

Other devices from Cargus International, Inc

See all devices from Cargus International, Inc →

Properties

  • Sterilise before use
  • Single use
  • Lot / batch number
  • Expiration date
  • Manufacturing date

Other properties (10)

  • Supplied sterile: 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