FDA UDI
In Commercial Distribution
🇺🇸 United States
DRGEM
DI: 08800011150082
·
Model: JADE-32
·
DRGEM Corporation
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- DRGEM
- Primary DI
- 08800011150082
- Version / Model
- JADE-32
- Company Name
- DRGEM Corporation
- Labeler DUNS
- 688477319
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-02-11
- Public Version
- 1
- Public Version Date
- 2019-03-11
- Public Version Status
- New
- Public Device Record Key
- 6b304e19-ece3-4cf7-a75b-d217bdbc3703
Device Description
100~240V~ 120kV
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 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37626 | Mobile basic diagnostic x-ray system, analogue | An assembly of devices that comprise an analogue general-purpose mobile diagnostic x-ray system used in a variety of routine x-ray imaging applications. It is typically an x-ray film based system using analogue or analogue-to-digital techniques for image capture and display. The mobile design allows it to operate on-line or by battery and to be driven or pushed by an operator to various locations within a building. 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 | 08800011150082 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K183388 | 000 |