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Microtek 1

by Microtek Medical LLC 1,000+ variants

Microtek 1 is a Class II device made by Microtek Medical LLC, listed in FDA GUDID since 16 Nov 2016 (UDI-DI 00748426077540), 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 Number00748426077540 UDI-DI Date16 Nov 2016ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
Microtek
Generic name
Subcutaneous self-injection aid
Model / reference
1
Primary DI / UDI-DI
00748426077540
FDA product code
KKX
GMDN term
Subcutaneous self-injection aid
Device class
Class II
Regulation number
878.4370
GUDID distribution status
In Commercial Distribution
Sterilisation method
Ethylene Oxide

Related devices

Category: Subcutaneous self-injection aid

Similar devices

Other devices filed under FDA product code KKX (Drape, surgical).

Other devices from Microtek Medical LLC

See all devices from Microtek Medical LLC →

Properties

  • Supplied sterile
  • Sterilise before use
  • Single use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)