Duns Number:401020409
Device Description: Irrigation set for TURP with Laser Cooling line
Catalog Number
ONGR2001ST12
Brand Name
Urology Gravity Laser Cooling Line
Version/Model Number
GB1BPH
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
GBX
Product Code Name
Catheter, Irrigation
Public Device Record Key
76ad3426-ac24-4bbe-8458-78d637fd92c5
Public Version Date
February 11, 2020
Public Version Number
2
DI Record Publish Date
October 18, 2019
Package DI Number
03700512922018
Quantity per Package
4
Contains DI Package
03700512902010
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 |