Duns Number:627879687
Device Description: The Torrent irrigation scope connector Pentax is used with the Torrent irrigation tubing t The Torrent irrigation scope connector Pentax is used with the Torrent irrigation tubing to provide irrigation fluids such as sterile water during gastrointestinal endoscopic procedures when used in conjunction with an irrigation pump (or electrosurgical unit).
Catalog Number
00711571
Brand Name
Torrent
Version/Model Number
00711571
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
792d297f-1410-40a5-bfc2-1cdd698d3b98
Public Version Date
June 10, 2022
Public Version Number
4
DI Record Publish Date
April 01, 2020
Package DI Number
10724995184008
Quantity per Package
100
Contains DI Package
00724995184001
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 |