Identity
- Trade Name
- ATEC Breast Biopsy and Excision System Aurora Angled Needle Guide EUDAMEDATEC Needle Guide FDA UDI
- Generic Name
- Side-notch biopsy gun handpiece/needle FDA UDI
- Device Name
- ATEC and Eviva Breast Biopsy and Excision System - Needle Guides and Tissue Filter EUDAMEDANGLED NEEDLE GUIDE FOR THE AURORA MRI SYSTEM FDA UDI
- Model / Reference
- ATEC_NG09-A2 EUDAMEDFDA UDI
- Description
- ANGLED NEEDLE GUIDE FOR THE AURORA MRI SYSTEM FDA UDI
Identifiers
- Catalog Number
- ATEC_NG09-A2 FDA UDI
- Primary DI / UDI-DI
- 05420045503154 EUDAMEDFDA UDI
- Basic UDI-DI
- 54200455BRSTSNGTFGK EUDAMED
- Direct Marketing DI
- 05420045503154 EUDAMED
- 510(k) Number
- K042290 FDA UDI
- FDA Product Code
- KNW FDA UDI
- EMDN Code
- A018002 NEEDLE GUIDES EUDAMED
- GMDN Term
- Side-notch biopsy gun handpiece/needle FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1075 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Side-notch biopsy gun handpiece/needle
ATEC Needle Guide by Hologic, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Side-notch biopsy gun handpiece/needle.
- M-Biopsy — Mermaid Medical A/S · Class II
- Disposable Automatic Biopsy Gun — Möller Medical GmbH · Class II
- Disposable Semi-Automatic Biopsy Gun — Möller Medical GmbH · Class II
- M-Biopsy — Mermaid Medical A/S · Class II
- MONOPTY — Bard Peripheral Vascular · Class II
- M-Biopsy — Mermaid Medical A/S · Class II
- TOP CUT — H.S. HOSPITAL SERVICE SPA · Class II
- M-Biopsy — Mermaid Medical A/S · Class II
Cleared under the same submission
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Hologic, Inc.
Sources (2)
- FDA UDI 67d9397d-de09-40a7-8263-716ed96b90a8 36 fields · synced Jul 17, 2026
- EUDAMED f2a64250-65d0-44c8-a828-60684a363d17 61 fields · synced Jul 17, 2026