Duns Number:187129135
Device Description: Designed for patients 2 years and older for Temporary indwelling ureteral catheter to assi Designed for patients 2 years and older for Temporary indwelling ureteral catheter to assist in urine drainage
Catalog Number
-
Brand Name
Silhouette® Pediatric Ureteral Stent with Urowire® Guidewire
Version/Model Number
B3884
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
EZB
Product Code Name
Stylet For Catheter, Gastro-Urology
Public Device Record Key
a9ed191e-8997-4283-8baf-2512ac0364a6
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
July 16, 2015
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 | 499 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 698 |
| 3 | A medical device with high risk that requires premarket approval | 1 |