FDA UDI
In Commercial Distribution
🇺🇸 United States
SKANMOBILE DR
DI: 08904269403683
·
Model: 303-000018-16
·
SKANRAY TECHNOLOGIES LIMITED
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SKANMOBILE DR
- Primary DI
- 08904269403683
- Version / Model
- 303-000018-16
- Company Name
- SKANRAY TECHNOLOGIES LIMITED
- Labeler DUNS
- 863358955
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-04-21
- Public Version
- 1
- Public Version Date
- 2022-04-29
- Public Version Status
- New
- Public Device Record Key
- 7d18cb9e-69e3-4bf0-837a-afe80b11f0a2
Device Description
SKANMOBILE DR is a digital radiographic system designed for superior image quality featuring wireless flat panel detector and operator console for digital imaging integrated with high frequency generator.
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
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| IZL | System, X-Ray, Mobile | Radiology | 892.1720 | 2 |
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | Radiology | 892.1680 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37647 | Mobile basic diagnostic x-ray system, digital | An assembly of devices that comprise a digital general-purpose mobile diagnostic x-ray system used in a variety of routine planar x-ray imaging applications. It uses digital techniques for image capture, display and manipulation and the mobile design allows it to operate on mains or battery power and to be driven or pushed by an operator to various locations within a building or facility. It is commonly used for bedside imaging and for interventional and intraoperative imaging. It consists of basic modular configurations that can be upgraded. This GMDN code does not cover systems with fluoroscopic or tomographic capabilities. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08904269403683 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K212940 | 000 |