FDA UDI
In Commercial Distribution
🇺🇸 United States
RadiForce®
DI: 04995047040231
·
Model: GX340
·
EIZO CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- RadiForce®
- Primary DI
- 04995047040231
- Version / Model
- GX340
- Catalog Number
- GX340-CL-BK
- Company Name
- EIZO CORPORATION
- Labeler DUNS
- 691033005
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-12
- Public Version
- 4
- Public Version Date
- 2022-10-24
- Public Version Status
- Update
- Public Device Record Key
- 9c743a39-4125-470c-a68e-520d3e35a8da
Device Description
3MP Monochrome LCD Monitor
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 |
|---|---|---|---|---|
| LLZ | System, Image Processing, Radiological | Radiology | 892.2050 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36615 | Image display unit, monochrome | An electrically-powered visual display unit (VDU), commonly known as a screen or a monitor, designed for displaying graphical information under program control in only one text/image colour, e.g., measured values or images from other devices. The information displayed will be limited (the view will become confusing to the user when too much information is shown). A keyboard may be connected for interactive manipulation of the data by the user. This group of devices is the product identifier for the monitor only and does not include the device(s) from which the data is generated and includes different screen technologies, e.g., cathode-ray tube (CRT) or liquid crystal display (LCD). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04995047040231 | GS1 |
Customer Contacts
- Phone
- 1-888-900-8383
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K113784 | 000 |