Duns Number:686908512
Catalog Number
-
Brand Name
StopCon-Cap Olympus® Cap with Air/Water tubing for Olympus®
Version/Model Number
EN10901B
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"
-
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
OCX
Product Code Name
Endoscopic Irrigation/Suction System
Public Device Record Key
c37e6291-03fd-4d79-a4f0-56dad41a9cfc
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
January 31, 2022
Package DI Number
14897106952257
Quantity per Package
10
Contains DI Package
04897106952250
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 8 |
2 | A medical device with a moderate to high risk that requires special controls. | 3 |