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Tracking Bracket Starter Kit 657-113

by Civco Medical Instruments Co., Inc.

Ref 657-113

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

8 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00841436126212 UDI-DI Date27 Jul 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number0841436101TD103A2dUH Basic UDI-DI 00841436126212UDI-DIDate26 May 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

17 recalls · 8 ongoing · FDA

  • 8 recalls, same reason

    • Ongoing Z-1738-2026 FDA Class II initiated 2 Mar 2026
    • Ongoing Z-1736-2026 FDA Class II initiated 2 Mar 2026
    • Ongoing Z-1735-2026 FDA Class II initiated 2 Mar 2026
    • Ongoing Z-1737-2026 FDA Class II initiated 2 Mar 2026
    • Ongoing Z-1732-2026 FDA Class II initiated 2 Mar 2026
    • Ongoing Z-1731-2026 FDA Class II initiated 2 Mar 2026
    • Ongoing Z-1734-2026 FDA Class II initiated 2 Mar 2026
    • Ongoing Z-1733-2026 FDA Class II initiated 2 Mar 2026

    There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.

  • 4 recalls, same reason

    • Terminated Z-0396-2022 FDA Class II initiated 8 Oct 2021
    • Terminated Z-0397-2022 FDA Class II initiated 8 Oct 2021
    • Terminated Z-0398-2022 FDA Class II initiated 8 Oct 2021
    • Terminated Z-0395-2022 FDA Class II initiated 8 Oct 2021

    There is potential that the VirtuTRAX device will not tighten onto the instrument to be used.

  • 5 recalls, same reason

    • Terminated Z-1955-2012 FDA Class II initiated 7 May 2012
    • Terminated Z-1952-2012 FDA Class II initiated 7 May 2012
    • Terminated Z-1953-2012 FDA Class II initiated 7 May 2012
    • Terminated Z-1954-2012 FDA Class II initiated 7 May 2012
    • Terminated Z-1956-2012 FDA Class II initiated 7 May 2012

    The general purpose electromagnetic sensor was incorrectly calibrated causing potential variability in the projected position of the needle path with the ultrasound device.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Tracking Bracket Starter Kit
Generic Name
Electromagnetic surgical navigation/tracking system
Device Name
Electromagnetic Tracking – Tracking Tools (Endocavity Tracking Brackets)
Model / Ref / Catalog
657-113
Primary DI / UDI-DI
00841436126212
Basic UDI-DI
0841436101TD103A2dUH
Direct Marketing DI
20841436126209
510(k) Number
FDA Product Code
IYO
EMDN Code
Z11039099 Various radiodiagnostic and interventional instruments – other
GMDN Term
Electromagnetic surgical navigation/tracking system
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
892.1560
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Related devices

Cleared under the same submission (K092619)

Show all (12)

Other devices from Civco Medical Instruments Co., Inc.

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Properties

  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (19)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No