Duns Number:627879687
Device Description: The BioShield EUS biopsy valve-linear is used to cover the opening to the biopsy, suction The BioShield EUS biopsy valve-linear is used to cover the opening to the biopsy, suction channel of flexible gastrointestinal endoscopes. 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
00711903
Brand Name
BioShield
Version/Model Number
00711903
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
K202583,K202583
Product Code
ODD
Product Code Name
Endoscopic retrograde cholangiopancreatography (ERCP) cannula
Public Device Record Key
cddcef30-e08f-4f87-b0c2-ed0d3bb58aed
Public Version Date
September 23, 2021
Public Version Number
1
DI Record Publish Date
September 15, 2021
Package DI Number
10724995199255
Quantity per Package
25
Contains DI Package
00724995199258
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| 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 |