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GD Prep-Check 10Hz

by General Devices

Listed FDA GUDID listing, not in commercial distribution

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

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00862186000300 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: not 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  • Withdrawn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
Gd
Generic Name
Electrocardiographic electrode tester
Model / Ref / Catalog
Prep-Check 10Hz, EIM-105-10Hz
Primary DI / UDI-DI
00862186000300
FDA Product Code
KRC
GMDN Term
Electrocardiographic electrode tester
Device Class
Class II
Regulation Number
870.2370
GUDID distribution status
Not in Commercial Distribution

Other devices from General Devices

See all devices from General Devices →

Properties

  • Over-the-Counter
  • Serial Number

Other properties (12)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No