Identity
- Trade Name
- Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System EUDAMEDneoprobe FDA UDI
- Generic Name
- Hand-held-detector nuclear medicine system FDA UDI
- Device Name
- Probe EUDAMEDOperation Manual Kit, Model 2300 FDA UDI
- Model / Reference
- MRPROBE08 EUDAMEDNPSW601 FDA UDI
- Description
- Operation Manual Kit, Model 2300 FDA UDI
Identifiers
- Catalog Number
- NPSW601 FDA UDI
- Primary DI / UDI-DI
- 00841911100355 EUDAMEDFDA UDI
- Basic UDI-DI
- 08419111AD10C000003322QP EUDAMED
- FDA Product Code
- IZD FDA UDI
- EMDN Code
- A019012 BREAST NODULES AND OTHER STRUCTURES LOCALISATION NEEDLES AND SYSTEMS EUDAMED
- GMDN Term
- Hand-held-detector nuclear medicine system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 892.1320 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
neoprobe by Devicor Medical Products, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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 I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Devicor Medical Products, Inc.
Sources (2)
- FDA UDI ae31fdae-e0aa-4ecf-a630-d640ddd6579d 37 fields · synced Jul 9, 2026
- EUDAMED 56f74150-534b-43df-b6a0-b63dc4ccf2ed 61 fields · synced Jul 9, 2026