Duns Number:216745893
Device Description: ARV140 Size 4 (Xl) Endocuff Vision Orange Sterilised - 1 pot - single unit
Catalog Number
-
Brand Name
Endocuff Vision
Version/Model Number
ARV140
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
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"
Yes
For Single-Use
Yes
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
FED
Product Code Name
Endoscopic Access Overtube, Gastroenterology-Urology
Public Device Record Key
2acd9a94-76ce-4d69-94c4-f2d795ab725d
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 09, 2016
Package DI Number
5060423410232
Quantity per Package
120
Contains DI Package
5060423410072
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shipper
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8 |