Duns Number:544427443
Device Description: This equipment has been designed to be used to process signals from an endoscope and conve This equipment has been designed to be used to process signals from an endoscope and convert it to a signal that can be displayed on the monitor.
Catalog Number
-
Brand Name
Eview
Version/Model Number
PV220
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FET
Product Code Name
Endoscopic Video Imaging System/Component, Gastroenterology-Urology
Public Device Record Key
2f4c6459-ee1e-4edf-8d78-795d3352f8b7
Public Version Date
March 24, 2021
Public Version Number
1
DI Record Publish Date
March 16, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |