Duns Number:401020409
Device Description: Irrigation/Aspiration set for RTUP/Post Operative irrigation (Urology) - 2 spikes - pump s Irrigation/Aspiration set for RTUP/Post Operative irrigation (Urology) - 2 spikes - pump segment
Catalog Number
SOUR9212ST12
Brand Name
Urology TURP Post-Op Extra Spike
Version/Model Number
RF2TURPPOES
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
698c8f2b-c9e7-4dbd-b9b5-169d9546c4f3
Public Version Date
February 11, 2020
Public Version Number
3
DI Record Publish Date
October 21, 2019
Package DI Number
03700512922087
Quantity per Package
2
Contains DI Package
03700512912088
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 |