Duns Number:305524696
Device Description: Double loop ureteral stent in silicone open/open without eye in the straight section CH FR Double loop ureteral stent in silicone open/open without eye in the straight section CH FR 08 length 28 cm with connectable pusher and fixed core guidewire
Catalog Number
AJ4U85
Brand Name
Porges Coloplast
Version/Model Number
AJ4U85
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
K013921
Product Code
FAD
Product Code Name
STENT, URETERAL
Public Device Record Key
5100fd19-c37b-46b4-b0d7-639f55aacbcd
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 24, 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 | 46 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 899 |
| 3 | A medical device with high risk that requires premarket approval | 72 |
| U | Unclassified | 7 |