Duns Number:305524696
Device Description: In-Ka® Percutaneous Balloon Dilatation CatheterBalloon dilation catheter for percutaneous In-Ka® Percutaneous Balloon Dilatation CatheterBalloon dilation catheter for percutaneous access + inflation device
Catalog Number
BD3020
Brand Name
Porges Coloplast
Version/Model Number
BD3020
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
-
Product Code
LJE
Product Code Name
CATHETER, NEPHROSTOMY
Public Device Record Key
b3ff8b57-7a3f-4b7a-ab5b-59f976e45c42
Public Version Date
February 01, 2021
Public Version Number
1
DI Record Publish Date
January 22, 2021
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 |