Duns Number:305524696
Device Description: ImaJin™ Silicone hydro-coated Double loop ureteral stent open/open CH FR 06 length 28 cm w ImaJin™ Silicone hydro-coated Double loop ureteral stent open/open CH FR 06 length 28 cm with steerable pusher CH FR 06 and Orchestra™ guidewire
Catalog Number
BCHS65
Brand Name
Porges Coloplast
Version/Model Number
BCHS65
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
K180469
Product Code
FAD
Product Code Name
STENT, URETERAL
Public Device Record Key
0364d52a-e9e2-4976-bd3b-05eeec5b8903
Public Version Date
April 08, 2019
Public Version Number
1
DI Record Publish Date
March 29, 2019
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 |