Identity
- Trade Name
- Mammotome Specimen Trays EUDAMEDFAXITRON MAMMOTOME FDA UDI
- Generic Name
- Tissue specimen x-ray system IVD FDA UDI
- Device Name
- Faxitron Radiography System EUDAMEDContainer with a base and a lid to hold surgical specimen sample for the purpose of x-ray imaging that sample FDA UDI
- Model / Reference
- 120-807604 EUDAMEDFDA UDI
- Description
- Container with a base and a lid to hold surgical specimen sample for the purpose of x-ray imaging that sample FDA UDI
Identifiers
- Primary DI / UDI-DI
- 25420045516646 EUDAMEDFDA UDI
- Basic UDI-DI
- 54200455FAXITRONCABXRAYBU EUDAMED
- Direct Marketing DI
- 25420045516646 EUDAMED
- 510(k) Number
- K082432 FDA UDI
- FDA Product Code
- MWP FDA UDI
- EMDN Code
- Z11069005 DIAGNOSTIC IMAGING WORKSTATIONS EUDAMED
- GMDN Term
- Tissue specimen x-ray system IVD FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1680 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Tissue specimen x-ray system IVD
Faxitron Mammotome by Hologic, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
K082432 also covers:
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 230159b3-546a-4d07-8101-2a9f019b4d15 35 fields · synced Jul 10, 2026
- EUDAMED 166f24fd-12d1-4a9c-a252-83010776224e 61 fields · synced Jul 10, 2026