Duns Number:305524696
Device Description: In-Ka Ureteral Balloon Dilatation Catheter + Inflation device (manometer)Balloon Dilation In-Ka Ureteral Balloon Dilatation Catheter + Inflation device (manometer)Balloon Dilation with inflation device, diameter of the balloon 4 mm, body tube length 75 cm, radiopaque stainless-steel rings + inflation device
Catalog Number
BD4044
Brand Name
Porges Coloplast
Version/Model Number
BD4044
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
EZN
Product Code Name
DILATOR, CATHETER, URETERAL
Public Device Record Key
7ddec7d0-16ec-45d8-a17c-d750a70b232b
Public Version Date
June 29, 2020
Public Version Number
1
DI Record Publish Date
June 19, 2020
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 |