FDA UDI
In Commercial Distribution
🇺🇸 United States
Volpara Live
DI: 09421904268340
·
Model: 2.4
·
VOLPARA HEALTH TECHNOLOGIES LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Volpara Live
- Primary DI
- 09421904268340
- Version / Model
- 2.4
- Company Name
- VOLPARA HEALTH TECHNOLOGIES LIMITED
- Labeler DUNS
- 590762212
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-05-06
- Public Version
- 2
- Public Version Date
- 2025-08-15
- Public Version Status
- Update
- Public Device Record Key
- 349b364b-4087-473a-91a3-5efc7d6df651
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| LHO | Instrument, Quality-Assurance, Radiologic | Radiology | 892.1940 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47817 | Radiological video camera patient positioning/tracking system software | A software application intended to be installed on a radiological workstation or computer as part of a radiological video camera patient positioning/tacking system for the acquisition, viewing, monitoring, processing, and analysis of three-dimensional (3-D) surface images of a patient anatomy during diagnostic imaging, radiation treatment planning, and/or radiation therapy, without the use of patient markers. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 09421904268340 | GS1 |