FDA UDI
In Commercial Distribution
🇺🇸 United States
CuratOR
DI: 04995047062035
·
Model: EX3141-3D
·
EIZO CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- CuratOR
- Primary DI
- 04995047062035
- Version / Model
- EX3141-3D
- Catalog Number
- EX3141-3D-WT
- Company Name
- EIZO CORPORATION
- Labeler DUNS
- 691033005
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-07-30
- Public Version
- 3
- Public Version Date
- 2023-09-13
- Public Version Status
- Update
- Public Device Record Key
- 0d118b09-e586-40e6-b6f3-1c8ee1685dd9
Device Description
31.1-inch 4K UHD 3D 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
- Yes
- 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 |
|---|---|---|---|---|
| KQM | Camera, Surgical And Accessories | General, Plastic Surgery | 878.4160 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 56654 | Endoscopic video image display unit | An electrically-powered visual display unit (VDU), commonly known as a screen or a monitor, designed to be used exclusively in conjunction with a video endoscope to display to the operator the graphical information captured by the endoscope to facilitate its manipulation during the endoscopic procedure; typically difficult and non-difficult intubation procedures to maintain an open airway. It is typically a portable device with a liquid crystal display (LCD) colour screen and a direct electronic signal connection to the endoscope. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04995047062035 | GS1 | ||||
| Previous | 04995047053422 | GS1 |
Customer Contacts
- Phone
- 1-888-900-8383
- [email protected]