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D619GC

by Parkell, Inc.

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberM595D619GC0 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  • Withdrawn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

Generic name
Endodontic apex locator
Model / Ref / Catalog
D619GC
Primary DI / UDI-DI
M595D619GC0
FDA product code
LQY
GMDN term
Endodontic apex locator
Device class
U
GUDID distribution status
Not in Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Other devices from Parkell, Inc.

See all devices from Parkell, Inc. →

Properties

  • Sterilise before use
  • Prescription use

Other properties (13)

  • Supplied sterile: No
  • Single use: No
  • Implantable: No
  • Contains latex: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Lot / batch number: No
  • Serial number: No
  • Expiration date: No
  • Manufacturing date: No