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Eviva Needle Guide
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref EVIVA_NG09LRef EVIVA_NG12RRef EVIVA_NG12L
Identity
- Trade Name
- Eviva Needle Guide EUDAMEDFDA 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 EUDAMEDNEEDLE GUIDE, 9GA, ROUND, EVIVA FDA UDINEEDLE GUIDE, 9GA, FOR FISCHER PRONE AND LORAD FDA UDINEEDLE GUIDE, 12GA, FOR FISCHER PRONE AND LORAD FDA UDINEEDLE GUIDE, 12GA, ROUND, EVIVA FDA UDI
- Model / Reference
- EVIVA_NG09L EUDAMEDFDA UDIEVIVA_NG12L EUDAMEDFDA UDIEVIVA_NG12R EUDAMEDFDA UDIEVIVA_NG09R FDA UDI
- Description
- NEEDLE GUIDE, 9GA, ROUND, EVIVA FDA UDINEEDLE GUIDE, 9GA, FOR FISCHER PRONE AND LORAD FDA UDINEEDLE GUIDE, 12GA, FOR FISCHER PRONE AND LORAD FDA UDINEEDLE GUIDE, 12GA, ROUND, EVIVA FDA UDI
Identifiers
- Catalog Number
- EVIVA_NG09R FDA UDIEVIVA_NG09L FDA UDIEVIVA_NG12L FDA UDIEVIVA_NG12R FDA UDI
- Primary DI / UDI-DI
- 05420045503710 EUDAMEDFDA UDI05420045503734 EUDAMEDFDA UDI15420045504615 EUDAMEDFDA UDI15420045504608 FDA UDI
- Basic UDI-DI
- 54200455BRSTSNGTFGK EUDAMED
- Direct Marketing DI
- 05420045503710 EUDAMED15420045504615 EUDAMED05420045503734 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
Eviva 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 (7)
- FDA UDI 18324a1e-379a-463f-87a3-8009d24a0a14 36 fields · synced Aug 2, 2026
- FDA UDI 84479fcb-b1ec-4b42-a917-26cfc062e27c 36 fields · synced May 30, 2026
- FDA UDI 748594c8-8453-416d-a2f6-4554858c9ca0 36 fields · synced May 30, 2026
- FDA UDI 350eeaf6-caa9-4ea5-a6ea-22da42602213 36 fields · synced May 30, 2026
- EUDAMED 7fecd519-68ca-4710-aae2-fdfa5cb153f8 61 fields · synced Jul 15, 2026
- EUDAMED b5073eae-0e56-49fe-adb4-2a87b20d76fe 61 fields · synced Jul 30, 2026
- EUDAMED a3a006fa-6db1-4230-943c-b1f6495fd110 61 fields · synced Aug 2, 2026