Duns Number:627879687
Device Description: The UroSeal adjustable endoscopic valve is used to cover the opening to the biopsy/suction The UroSeal adjustable endoscopic valve is used to cover the opening to the biopsy/suction channel of an endoscope. It provides access for endoscopic device passage and exchange, helps maintain insufflation, minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure and provides access for irrigation.
Catalog Number
00913410
Brand Name
UroSeal
Version/Model Number
00913410
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 31, 2020
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
K070420,K070420
Product Code
ODD
Product Code Name
Endoscopic retrograde cholangiopancreatography (ERCP) cannula
Public Device Record Key
d336aca4-2b68-4599-8fd8-ba1dbb658d3e
Public Version Date
March 19, 2021
Public Version Number
7
DI Record Publish Date
September 17, 2016
Package DI Number
10816765012489
Quantity per Package
5
Contains DI Package
00816765012482
Package Discontinue Date
March 31, 2020
Package Status
Not 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 | 51 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 902 |