FDA UDI
In Commercial Distribution
🇺🇸 United States
MicroDose SI
DI: 00884838070943
·
Model: L50
·
Philips Digital Mammography Sweden AB
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MicroDose SI
- Primary DI
- 00884838070943
- Version / Model
- L50
- Catalog Number
- 714048
- Company Name
- Philips Digital Mammography Sweden AB
- Labeler DUNS
- 632899233
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-31
- Public Version
- 4
- Public Version Date
- 2021-08-02
- Public Version Status
- Update
- Public Device Record Key
- 4614fee8-ebbd-4191-92cf-e74dfb702ec0
Device Description
Philips MicroDose Mammography SI L50 is intended to produce radiographic images of the human breast for the purpose of diagnostic and screening mammography. The system is intended to be used in the same clinical applications as traditional film-based mammography systems.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- Yes
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MUE | Full field digital,system,x-ray,mammographic | Radiology | 892.1715 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37672 | Stationary mammographic x-ray system, digital | A stationary assembly of devices designed to generate x-ray images of the breast using digital techniques for image capture and display. It is designed specifically to compress the breast during imaging and is intended to visually evaluate the anatomy and function of blood and lymphatic vessels within the breast. Often referred to as a digital mammography system (DMS) it is typically used for breast cancer screening or during biopsy procedures (e.g., placement of biopsy markers, stereotactic biopsy). It is designed to capture two-dimensional (2-D) x-ray images, however may include software intended to process multiple images to create a three-dimensional (3-D) image/model (tomosynthesis). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00884838070943 | GS1 |