Identity
- Trade Name
- MAMMOBED FDA UDI
- Generic Name
- Mammographic biopsy x-ray table, powered FDA UDI
- Device Name
- It's a special table on wheels for stereotactic breast biopsy procedures with patient in prone position. FDA UDI
- Model / Reference
- MAMMOBED FDA UDI
- Description
- It's a special table on wheels for stereotactic breast biopsy procedures with patient in prone position. FDA UDI
Identifiers
- Catalog Number
- 6100-06M1 FDA UDI
- Primary DI / UDI-DI
- 08033837190301 FDA UDI
- 510(k) Number
- K925212 FDA UDI
- FDA Product Code
- IZH FDA UDI
- GMDN Term
- Mammographic biopsy x-ray table, powered FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1710 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Height — 1560 Millimeter FDA UDIDepth — 740 Millimeter FDA UDIWidth — 1900 Millimeter FDA UDI
Category: Mammographic biopsy x-ray table, powered
Mammobed by I.m.s. Internazionale Medico Scientifica Srl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K925212 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- I.m.s. Internazionale Medico Scientifica Srl
Sources (1)
- FDA UDI b59145b2-50c2-4a9f-94b1-6bf4d726bea5 37 fields · synced May 30, 2026