FDA UDI
In Commercial Distribution
🇺🇸 United States
MammoPad Radiolucent Cushion
DI: 45420045505798
·
Model: MP301
·
Hologic, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
25
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Basic Information
- Brand Name
- MammoPad Radiolucent Cushion
- Primary DI
- 45420045505798
- Version / Model
- MP301
- Catalog Number
- MP301
- Company Name
- Hologic, Inc.
- Labeler DUNS
- 139534114
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 25
- Record Status
- Published
- Publish Date
- 2016-05-13
- Public Version
- 7
- Public Version Date
- 2025-01-24
- Public Version Status
- Update
- Public Device Record Key
- ac7be096-4d50-49f7-b1eb-ecef232bd3f6
Device 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.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| IZH | System, x-ray, mammographic | Radiology | 892.1710 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40899 | Radiological breast positioner, non-wearable | A device that is specifically designed to ensure adequate positioning and immobilization of the female patient's breast(s) and chest during diagnostic imaging procedures, image-guided surgical or interventional procedures, and/or radiation therapy procedures. The device is in the form of a frame, board, cushion, or preformed pad (non-wearable device) and may also be used to facilitate reproducible positioning for serial imaging studies or serial radiation therapy treatments. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 45420045505798 | GS1 | ||||
| Unit of Use | 15420045505797 | GS1 | ||||
| Package | 35420045505791 | GS1 | BOX | 2 | In Commercial Distribution | |
| Package | 25420045505794 | GS1 | BAG | 1 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(800)442-9892
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K062141 | 000 |