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Scheker DRUJ DRUJ-H100

by Aptis Medical, LLC.

Scheker DRUJ-H100 is a surgical instrument handle (FDA Class I; FDA product code HXX, Screwdriver) made by Aptis Medical, LLC., listed in FDA GUDID since 24 Sep 2018 (UDI-DI B013DRUJH1000), 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 NumberB013DRUJH1000 UDI-DI Date24 Sep 2018ListedStatusListed 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  • Withdrawn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
Scheker DRUJ
Generic name
Surgical instrument handle, non-torque-limiting
Model / Ref / Catalog
DRUJ-H100
Primary DI / UDI-DI
B013DRUJH1000
FDA product code
HXX
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

Similar devices in this category

Other devices filed under Surgical instrument handle, non-torque-limiting.

Other devices from Aptis Medical, LLC.

See all devices from Aptis Medical, LLC. →

Properties

  • Sterilise before use
  • Premarket exempt
  • Lot / batch number
Other properties (12, all answered No)