Duns Number:305524696
Device Description: X-FLOW® Prostatectomy catheter Dufour tip 3-way 30-50 ml 100% silicone CH FR 18
Catalog Number
AB6318
Brand Name
Porges Coloplast
Version/Model Number
AB6318
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
K013172,K013172
Product Code
EZL
Product Code Name
CATHETER, RETENTION TYPE, BALLOON
Public Device Record Key
c75569f6-9ec6-4046-952b-7b648221d3cb
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 01, 2016
Package DI Number
03600040144190
Quantity per Package
5
Contains DI Package
03600040144183
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Retail box
| 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 |