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MARK3 2124

by Cargus International, Inc

MARK3 2124 is a Class II device made by Cargus International, Inc, listed in FDA GUDID since 1 Dec 2016 (UDI-DI D79621241), registry data as of 22 Oct 2026.

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

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberD79621241 UDI-DI Date1 Dec 2016ListedStatusListed 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  • Withdrawn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
Dental bib
Model / reference
2124
Primary DI / UDI-DI
D79621241
FDA product code
PEM
GMDN term
Dental bib
Device class
Class II
Regulation number
878.4370
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code PEM (Dental Barriers And Sleeves).

Other devices from Cargus International, Inc

See all devices from Cargus International, Inc →

Properties

  • Lot / batch number
Other properties (14, all answered No)