FDA UDI
In Commercial Distribution
🇺🇸 United States
Villa Sistemi Medicali
DI: 08057737122514
·
Model: Tele VD3
·
VILLA SISTEMI MEDICALI SPA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Villa Sistemi Medicali
- Primary DI
- 08057737122514
- Version / Model
- Tele VD3
- Company Name
- VILLA SISTEMI MEDICALI SPA
- Labeler DUNS
- 439173964
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 3
- Public Version Date
- 2019-03-28
- Public Version Status
- Update
- Public Device Record Key
- 29d2fc88-e676-475a-8cef-d427d7f97e69
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| IXY | Holder, Radiographic Cassette, Wall-Mounted | Radiology | 892.1880 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37627 | Thoracic public health screening x-ray system | An assembly of medical devices designed to be used only for radiographic screening of the chest of large numbers of individuals within a short time frame. It typically has a simple configuration used to generate, control x-ray beams and record the absorption patterns of x-rays passing through a targeted body area. It is also referred to as a mass screening system, intended to optimize the capability of users to visually evaluate images of the lungs or other chest organs using various viewing and archive media, e.g., film, paper, photo-stimulated phosphor plates, digital or video format. It is often used in a mobile imaging environment and is moved between different locations in a van. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08057737122514 | GS1 |