Duns Number:627879687
Device Description: The BioShield irrigator extension tubing is used for attachment to an auxiliary water pump The BioShield irrigator extension tubing is used for attachment to an auxiliary water pump for hands-free foot pedal irrigation control.
Catalog Number
00711134
Brand Name
BioShield
Version/Model Number
00711134
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
OCX
Product Code Name
endoscopic irrigation/suction system
Public Device Record Key
5c951246-3e5d-4063-8881-76c969230999
Public Version Date
September 14, 2021
Public Version Number
4
DI Record Publish Date
March 19, 2020
Package DI Number
10724995183568
Quantity per Package
50
Contains DI Package
00724995183561
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 |