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
PV210
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
6538898b-373d-448c-8335-dc6baf354d97
Public Version Date
May 19, 2020
Public Version Number
2
DI Record Publish Date
April 09, 2019
Package DI Number
16971176280040
Quantity per Package
1
Contains DI Package
06971176280043
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |