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Na Drill and Stop

by Dixi Medical France GUDID

Product code GZL

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number03664539003535 UDI-DIDate4 Apr 2022ListedStatusIn distribution

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Listed
  • Not covered

United States — GUDID listing Listed

Recalls

9 recalls · FDA

  • 9 recalls, same reason

    • Terminated Z-0535-2022 FDA Class II initiated 9 Dec 2021
    • Terminated Z-0542-2022 FDA Class II initiated 9 Dec 2021
    • Terminated Z-0541-2022 FDA Class II initiated 9 Dec 2021
    • Terminated Z-0540-2022 FDA Class II initiated 9 Dec 2021
    • Terminated Z-0538-2022 FDA Class II initiated 9 Dec 2021
    • Terminated Z-0537-2022 FDA Class II initiated 9 Dec 2021
    • Terminated Z-0536-2022 FDA Class II initiated 9 Dec 2021
    • Terminated Z-0534-2022 FDA Class II initiated 9 Dec 2021
    • Terminated Z-0539-2022 FDA Class II initiated 9 Dec 2021

    Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag

Specification

GUDID · synced 23 Oct 2026

Trade Name
Na
Generic Name
Depth electrode
Model / Ref / Catalog
DRILL AND STOP, KIP-ACS-515B
Primary DI / UDI-DI
03664539003535
510(k) Number
FDA Product Code
GZL
GMDN Term
Depth electrode
Device Class
Class II
Regulation Number
882.1330
Commercial Distribution
In Commercial Distribution
MRI Safety
MR Unsafe

Related devices

Category: Depth electrode

Cleared under the same submission (K170959)

Show all (12)

Other devices from Dixi Medical

See all devices from Dixi Medical →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
Other properties (9)
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No

Sources (1)

  • FDA UDI c2aac104-6498-4dde-8fec-52b17efd6b44 36 fields · synced 23 Oct 2026