FDA UDI
In Commercial Distribution
🇺🇸 United States
not applicable
DI: 00840682146845
·
Model: PRISTINA 2.0
·
GE MEDICAL SYSTEMS
Product Codes
2
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- not applicable
- Primary DI
- 00840682146845
- Version / Model
- PRISTINA 2.0
- Company Name
- GE MEDICAL SYSTEMS
- Labeler DUNS
- 266062561
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-02-16
- Public Version
- 2
- Public Version Date
- 2022-10-25
- Public Version Status
- Update
- Public Device Record Key
- 9196767e-dffa-4cf4-a1e8-6c7175733c1c
Device Description
Software Pristina Infinity
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
- No
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OTE | Digital breast tomosynthesis | Unknown | 3 | |
| MUE | Full field digital, system, x-ray, mammographic | Radiology | 892.1715 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36513 | Mammographic x-ray system stereotactic unit | A device that can only fulfil its purpose when used together with and enhance the function of a diagnostic mammographic x-ray system. It is used to take two pictures of a breast from two different angles. On the basis of this stereoscopic picture set, it is possible to determine the exact position of a lesion in the breast and a cytological sample of this will be taken. This device or technique may be built-in to some diagnostic x-ray systems for mammography. | No | Active |
| 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 | 00840682146845 | GS1 |