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Needle Guide Starter Kit 674-036

by Civco Medical Instruments Co., Inc. EUDAMEDGUDID

Active European Union and United States

Ref 674-036

Regulatory status

as of 28 Oct 2026

Recall ongoing. 1 ongoing FDA recall. See recalls

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0841436101TD101C1ND Basic UDI-DIDate16 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00841436107006 UDI-DIDate22 Aug 2017ListedStatusIn distribution

Coverage

2 jurisdictions

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 AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

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

7 recalls · 1 ongoing · FDA

    • Ongoing Z-1892-2025 FDA Class II initiated 1 May 2025

    During the attachment of the needle guide to the covered probe, the tight tolerance and fit of the needle guide can cause a pinhole breach in the transducer cover when latching the guide in place.

    • Terminated Z-2888-2018 FDA Class II initiated 23 Feb 2018

    A cover failed leak testing during validation testing of new needle guides from a replacement tool.

  • 5 recalls, same reason

    • Terminated Z-0286-2016 FDA Class II initiated 21 Oct 2015
    • Terminated Z-0288-2016 FDA Class II initiated 21 Oct 2015
    • Terminated Z-0289-2016 FDA Class II initiated 21 Oct 2015
    • Terminated Z-0290-2016 FDA Class II initiated 21 Oct 2015
    • Terminated Z-0287-2016 FDA Class II initiated 21 Oct 2015

    Sterility of the product cannot be assured.

Specification

EUDAMED · GUDID

Trade Name
Needle Guide Starter Kit
Generic Name
Ultrasound imaging system tracking positioner, reusable
Device Name
General Purpose Guidance – In-Plane, Open Channel (Infiniti plus guide)
Model / Ref / Catalog
674-036
Primary DI / UDI-DI
00841436107006
Basic UDI-DI
0841436101TD101C1ND
Direct Marketing DI
20841436116248
510(k) Number
FDA Product Code
ITX
EMDN Code
A018002 Needle guides
GMDN Term
Ultrasound imaging system tracking positioner, reusable
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
892.1570
Market of Registration
Germany
Commercial Distribution
In Commercial Distribution
Size
Length — 3.69 Inch
Height — 1.61 Inch

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Related devices

Category: Ultrasound imaging system tracking positioner, reusable

Cleared under the same submission (K093713)

Show all (12)

Other devices from Civco Medical Instruments Co., Inc.

See all devices from Civco Medical Instruments Co., Inc. →

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