Duns Number:216745893
Device Description: Olympus Size 3 Endocuff Vision Purple - Sterilised - 1 Pot
Catalog Number
-
Brand Name
Endocuff Vision
Version/Model Number
ARV130U
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
8efdb2b8-a0b9-4cac-b9eb-5657f2a3d1e2
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
January 23, 2017
Package DI Number
05060423410348
Quantity per Package
120
Contains DI Package
05060423410300
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 |