Identity
- Trade Name
- Mammotome Revolve™ Dual Vacuum-Assisted Breast Biopsy System EUDAMEDMammotome Revolve EX FDA UDI
- Generic Name
- Side-notch biopsy gun handpiece/needle FDA UDI
- Device Name
- Probe EUDAMEDRevolve EX Ultrasound Probe with Sleeve - System Registered- CE FDA UDI
- Model / Reference
- MHEX08S EUDAMEDFDA UDI
- Description
- Revolve EX Ultrasound Probe with Sleeve - System Registered- CE FDA UDI
Identifiers
- Catalog Number
- CA000460001 FDA UDI
- Primary DI / UDI-DI
- 00841911102342 EUDAMEDFDA UDI
- Basic UDI-DI
- 08419111AD02C000003322RG EUDAMED
- 510(k) Number
- K202012 FDA UDI
- FDA Product Code
- KNW FDA UDI
- EMDN Code
- A019012 BREAST NODULES AND OTHER STRUCTURES LOCALISATION NEEDLES AND SYSTEMS EUDAMED
- GMDN Term
- Side-notch biopsy gun handpiece/needle FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1075 FDA UDI
- Market of Registration
- Netherlands 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
No
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
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Side-notch biopsy gun handpiece/needle
Mammotome Revolve EX by Devicor Medical Products, 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
- Devicor Medical Products, Inc.
Sources (2)
- FDA UDI b9b5076d-39b2-4192-a4a6-b90ac8dde12d 35 fields · synced Jul 31, 2026
- EUDAMED 2837bb27-a415-4e0f-a725-d361a44d2d9f 61 fields · synced Jul 31, 2026