Duns Number:627879687
Device Description: The BioShield biopsy valve is used to cover the opening to the biopsy/suction channel inle The BioShield biopsy valve is used to cover the opening to the biopsy/suction channel inlet of a gastrointestinal endoscope. The BioShield biopsy valve provides access for endoscopic device passage and exchange, helps maintain insufflation and minimizes leakage of biomaterial from the biopsy port throughout the gastrointestinal endoscopic procedure.
Catalog Number
00711136
Brand Name
BioShield
Version/Model Number
00711136
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 17, 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
-
Product Code
ODD
Product Code Name
Endoscopic retrograde cholangiopancreatography (ERCP) cannula
Public Device Record Key
4bfb07cd-41a2-41eb-94b4-a0e93bc19bc8
Public Version Date
March 19, 2021
Public Version Number
7
DI Record Publish Date
September 17, 2016
Package DI Number
10816765011130
Quantity per Package
100
Contains DI Package
00816765011133
Package Discontinue Date
March 17, 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 |