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Eviva Needle Guide EVIVA_NG12L

by Hologic United States EUDAMEDGUDID

Ref EVIVA_NG12L

Product code KNWEMDN A018002

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number54200455BRSTSNGTFGK Basic UDI-DIDate8 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05420045503734 UDI-DIDate11 Aug 2016ListedStatusIn 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 AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Certificates: none listed in EUDAMED

Recalls

4 recalls · FDA

    • Terminated Z-2285-2010 FDA Unclassified (pre-2012) initiated 11 Aug 2010

    The firm received a customer complaint that the a device labeled as ATEC 0912-12 was actually ATEC 0912-20.

    • Terminated Z-1160-2010 FDA Unclassified (pre-2012) initiated 1 Feb 2010

    The product is labeled as ATEC0909-12 but it actually contains 0909-20.

    • Terminated Z-0275-2009 FDA Unclassified (pre-2012) initiated 22 Sep 2008

    The distal tip of the needle may become detached and remain in the patient, requiring surgical removal.

    • Terminated Z-0362-2007 FDA Unclassified (pre-2012) initiated 15 Dec 2006

    The handpiece package may have an incorrect part number on the inner package. Error could result in over-penetration of the biopsy needle.

Specification

EUDAMED · GUDID · synced 23 Oct 2026

Trade Name
Eviva Needle Guide
Generic Name
Side-notch biopsy gun handpiece/needle
Device Name
ATEC and Eviva Breast Biopsy and Excision System - Needle Guides and Tissue Filter
Model / Ref / Catalog
EVIVA_NG12L
Primary DI / UDI-DI
05420045503734
Basic UDI-DI
54200455BRSTSNGTFGK
Direct Marketing DI
05420045503734
510(k) Number
FDA Product Code
KNW
EMDN Code
A018002 Needle guides
GMDN Term
Side-notch biopsy gun handpiece/needle
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
876.1075
Market of Registration
Belgium
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

Related devices

Cleared under the same submission (K042290)

Show all (12)

Other devices from Hologic

See all devices from Hologic →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
Other properties (19)
  • 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
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No

Sources (2)

  • FDA UDI 748594c8-8453-416d-a2f6-4554858c9ca0 36 fields · synced 23 Oct 2026
  • EUDAMED 05420045503734|54200455BRSTSNGTFGK 61 fields · synced 2 Aug 2026