Duns Number:305524696
Device Description: VORTEK® Double loop ureteral stent with hydrogel coating open/open CH FR 06 length 22 cm w VORTEK® Double loop ureteral stent with hydrogel coating open/open CH FR 06 length 22 cm with steerable pusher CH FR 06 and Orchestra™ guidewire and Flush ureteric catheter CH FR 06
Catalog Number
BCFT67
Brand Name
Porges Coloplast
Version/Model Number
BCFT67
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
K170362
Product Code
FAD
Product Code Name
STENT, URETERAL
Public Device Record Key
688ab21d-eb31-4b41-8f0c-24e4cd2ebeb4
Public Version Date
July 06, 2018
Public Version Number
2
DI Record Publish Date
April 05, 2018
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 |