Duns Number:534155213
Device Description: The Ureteral Catheter Administration Kit is designed for the convenience of the user for a The Ureteral Catheter Administration Kit is designed for the convenience of the user for administration of gels or fluids into the urinary tract. The Ureteral Catheter Administration Kit contains:• Two (2) Syringe Adaptors • Two (2) Syringes, 20 mL• One (1) Ureteral Catheter, 7 Fr
Catalog Number
200006
Brand Name
Ureteral Catheter Administration Kit
Version/Model Number
UCAK
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"
-
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
OHR
Product Code Name
Catheter Care Tray
Public Device Record Key
409d14a2-8ad6-4a9c-81c3-97c79f3513d1
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
May 17, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |