Duns Number:401020409
Device Description: 1 Way Irrigation set Ureteroscopy with laser
Catalog Number
SOUR9107ST12
Brand Name
Urology - TRAXERFLOW
Version/Model Number
SOUR9107ST12
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
FHF
Product Code Name
System, Evacuator, Fluid
Public Device Record Key
5c28942e-13b3-4b24-ab0b-556e97988761
Public Version Date
November 11, 2019
Public Version Number
6
DI Record Publish Date
October 25, 2016
Package DI Number
03700512921110
Quantity per Package
4
Contains DI Package
03700512911111
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box label 2
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 64 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 152 |