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Universal 01-K04-8040

by Kalitec Direct LLC

Universal 01-K04-8040 is a Class I device made by Kalitec Direct LLC, listed in FDA GUDID since 9 Feb 2022 (UDI-DI B07301K048040), 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 NumberB07301K048040 UDI-DI Date9 Feb 2022ListedStatusListed 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  • Withdrawn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
Universal
Generic name
Surgical instrument handle, non-torque-limiting
Model / Ref / Catalog
01-K04-8040
Primary DI / UDI-DI
B07301K048040
FDA product code
HXC
GMDN term
Surgical instrument handle, non-torque-limiting
Device class
Class I
Regulation number
888.4540
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Surgical instrument handle, non-torque-limiting

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)