Duns Number:627879687
Device Description: The Torrent irrigation pump is used to provide irrigation in endoscopic procedures. This p The Torrent irrigation pump is used to provide irrigation in endoscopic procedures. This product is used exclusively for our loaner program.
Catalog Number
00711579
Brand Name
Torrent
Version/Model Number
00711579
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
-
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
KNS
Product Code Name
Unit, electrosurgical, endoscopic (with or without accessories)
Public Device Record Key
aaff32f9-5057-4242-89c9-352fcec1dbc5
Public Version Date
November 10, 2020
Public Version Number
2
DI Record Publish Date
April 01, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| 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 |