Identity
- Trade Name
- MammoPad Radiolucent Cushion FDA UDI
- Generic Name
- Radiological breast positioner, non-wearable FDA UDI
- Device Name
- The MammoPad® products are designed to provide padding for patient comfort and aid in positioning during radiologic visualization of the breast using x-ray or scintillation technology. FDA UDI
- Model / Reference
- MP301-10 FDA UDI
- Description
- The MammoPad® products are designed to provide padding for patient comfort and aid in positioning during radiologic visualization of the breast using x-ray or scintillation technology. FDA UDI
Identifiers
- Catalog Number
- MP301-10 FDA UDI
- Primary DI / UDI-DI
- 25420045507330 FDA UDI
- 510(k) Number
- K062141 FDA UDI
- FDA Product Code
- IZH FDA UDI
- GMDN Term
- Radiological breast positioner, non-wearable 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
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Radiological breast positioner, non-wearable
MammoPad Radiolucent Cushion by Hologic, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Radiological breast positioner, non-wearable.
- C-Qual™ — Medtec LLC · Class II
- Positioning Cushion — Medtec LLC · Class II
- SenoView Prone Breast Board — Aktina Corp. · Class II
- Monarch™ Overhead Arm Positioner — Medtec LLC · Class II
- C-Qual™ — Medtec LLC · Class II
- Quest™ — Qfix · Class II
- Arm Support — Medtec LLC · Class II
- Arm Support — Medtec LLC · Class II
Cleared under the same submission
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
- Hologic, Inc.
Sources (1)
- FDA UDI f8c1b084-4122-45d2-8f87-991fb4a34045 36 fields · synced May 30, 2026