Skip to content

Cosmolock 11-K01-0006

by Kalitec Direct LLC

Cosmolock 11-K01-0006 is a Class I device made by Kalitec Direct LLC, listed in FDA GUDID since 3 Jan 2020 (UDI-DI B07311K0100060), registry data as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberB07311K0100060 UDI-DI Date3 Jan 2020ListedStatusListed 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  • Withdrawn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
Cosmolock
Generic name
Instrument tray, reusable
Model / Ref / Catalog
11-K01-0006
Primary DI / UDI-DI
B07311K0100060
FDA product code
FSM
GMDN term
Instrument tray, reusable
Device class
Class I
Regulation number
878.4800
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Other devices from Kalitec Direct LLC

See all devices from Kalitec Direct LLC →

Properties

  • Sterilise before use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (11, all answered No)