FDA UDI
In Commercial Distribution
🇺🇸 United States
WiScope®
DI: 06972084140399
·
Model: OTU-A
·
Ningbo Wise Optomech Technology Corporation
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- WiScope®
- Primary DI
- 06972084140399
- Version / Model
- OTU-A
- Catalog Number
- 4201A0501W
- Company Name
- Ningbo Wise Optomech Technology Corporation
- Labeler DUNS
- 540094524
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-04-05
- Public Version
- 1
- Public Version Date
- 2023-04-13
- Public Version Status
- New
- Public Device Record Key
- e162b8a1-f89c-4c45-bfd5-05291407009b
Device Description
Image System, adapting to a monitor of 16:9 aspect ratio
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 |
|---|---|---|---|---|
| FGB | Ureteroscope And Accessories, Flexible/Rigid | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 18034 | Endoscopic video image processing unit | An electrically-powered device designed to receive and process the electronic signals sent from a video endoscope or endoscopic video camera; it does not include the endoscope nor light source and is not designed to control the endoscope. It may have additional features which compensate for/enhance the colour and light qualities provided. The resulting picture images are sent to and shown on a visual display unit (VDU), typically to assist the endoscope operator with an ongoing intervention and often to allow the patient visualization of the process; the images can be recorded on a video recorder or stored on computerized media. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06972084140399 | GS1 |