| Primary Device ID | 00860008483713 | 
| NIH Device Record Key | 91637db7-0ec4-416d-be1b-b8ee10d11542 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Uro-V Cystoscope | 
| Version Model Number | 1012 | 
| Catalog Number | 1012 | 
| Company DUNS | 118239699 | 
| Company Name | UROVIU CORP. | 
| Device Count | 1 | 
| DM Exempt | false | 
| Pre-market Exempt | false | 
| MRI Safety Status | Labeling does not contain MRI Safety Information | 
| Human Cell/Tissue Product | false | 
| Device Kit | false | 
| Device Combination Product | false | 
| Single Use | true | 
| Lot Batch | true | 
| Serial Number | true | 
| Manufacturing Date | true | 
| Expiration Date | true | 
| Donation Id Number | false | 
| Contains Natural Rubber Latex | false | 
| Labeled No Natural Rubber Latex | false | 
| RX Perscription | true | 
| OTC Over-The-Counter | false | 
| Phone | 650 397 5174 | 
| cs@uroviu.com | |
| Phone | 650 397 5174 | 
| cs@uroviu.com | |
| Phone | 650 397 5174 | 
| cs@uroviu.com | |
| Phone | 650 397 5174 | 
| cs@uroviu.com | |
| Phone | 650 397 5174 | 
| cs@uroviu.com | |
| Phone | 650 397 5174 | 
| cs@uroviu.com | |
| Phone | 650 397 5174 | 
| cs@uroviu.com | |
| Phone | 650 397 5174 | 
| cs@uroviu.com | |
| Phone | 650 397 5174 | 
| cs@uroviu.com | |
| Phone | 650 397 5174 | 
| cs@uroviu.com | |
| Phone | 650 397 5174 | 
| cs@uroviu.com | |
| Phone | 650 397 5174 | 
| cs@uroviu.com | |
| Phone | 650 397 5174 | 
| cs@uroviu.com | |
| Phone | 650 397 5174 | 
| cs@uroviu.com | |
| Phone | 650 397 5174 | 
| cs@uroviu.com | |
| Phone | 650 397 5174 | 
| cs@uroviu.com | |
| Phone | 650 397 5174 | 
| cs@uroviu.com | 
| Catheter Working Length | 254 Millimeter | 
| Catheter Working Length | 254 Millimeter | 
| Catheter Working Length | 254 Millimeter | 
| Catheter Working Length | 254 Millimeter | 
| Catheter Working Length | 254 Millimeter | 
| Catheter Working Length | 254 Millimeter | 
| Catheter Working Length | 254 Millimeter | 
| Catheter Working Length | 254 Millimeter | 
| Catheter Working Length | 254 Millimeter | 
| Catheter Working Length | 254 Millimeter | 
| Catheter Working Length | 254 Millimeter | 
| Catheter Working Length | 254 Millimeter | 
| Catheter Working Length | 254 Millimeter | 
| Catheter Working Length | 254 Millimeter | 
| Catheter Working Length | 254 Millimeter | 
| Catheter Working Length | 254 Millimeter | 
| Catheter Working Length | 254 Millimeter | 
| Handling Environment Temperature | Between -10 Degrees Celsius and 70 Degrees Celsius | 
| Handling Environment Temperature | Between -10 Degrees Celsius and 70 Degrees Celsius | 
| Handling Environment Temperature | Between -10 Degrees Celsius and 70 Degrees Celsius | 
| Handling Environment Temperature | Between -10 Degrees Celsius and 70 Degrees Celsius | 
| Handling Environment Temperature | Between -10 Degrees Celsius and 70 Degrees Celsius | 
| Handling Environment Temperature | Between -10 Degrees Celsius and 70 Degrees Celsius | 
| Handling Environment Temperature | Between -10 Degrees Celsius and 70 Degrees Celsius | 
| Handling Environment Temperature | Between -10 Degrees Celsius and 70 Degrees Celsius | 
| Handling Environment Temperature | Between -10 Degrees Celsius and 70 Degrees Celsius | 
| Handling Environment Temperature | Between -10 Degrees Celsius and 70 Degrees Celsius | 
| Handling Environment Temperature | Between -10 Degrees Celsius and 70 Degrees Celsius | 
| Handling Environment Temperature | Between -10 Degrees Celsius and 70 Degrees Celsius | 
| Handling Environment Temperature | Between -10 Degrees Celsius and 70 Degrees Celsius | 
| Handling Environment Temperature | Between -10 Degrees Celsius and 70 Degrees Celsius | 
| Handling Environment Temperature | Between -10 Degrees Celsius and 70 Degrees Celsius | 
| Handling Environment Temperature | Between -10 Degrees Celsius and 70 Degrees Celsius | 
| Handling Environment Temperature | Between -10 Degrees Celsius and 70 Degrees Celsius | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00860008483713 [Primary] | 
| FAJ | Cystoscope And Accessories, Flexible/Rigid | 
| Steralize Prior To Use | false | 
| Device Is Sterile | true | 
| Public Version Status | Update | 
| Device Record Status | Published | 
| Public Version Number | 2 | 
| Public Version Date | 2023-11-17 | 
| Device Publish Date | 2022-12-16 | 
| 00860008483713 - Uro-V Cystoscope | 2023-11-17The Uro-V cystoscope system consists of a multi-use handle with an LCD screen and a single-use cannula. The system is used for endoscopic diagnosis and infusion of irrigating fluid within the bladder and urethra. | 
| 00860008483713 - Uro-V Cystoscope | 2023-11-17 The Uro-V cystoscope system consists of a multi-use handle with an LCD screen and a single-use cannula. The system is used for e | 
| 00860008483720 - Uro-N Cystoscope | 2023-11-17 The Uro-N cystoscope system consists of a mulit-use handle with an LCD screeen and a single-use sterile cannula. The Uro-N is in |