Duns Number:305524696
Device Description: Cystometry catheter with balloon 10 ml 2-way CH FR 12
Catalog Number
AH5212
Brand Name
Porges Coloplast
Version/Model Number
AH5212
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)
Yes
Device labeled as "Not made with natural rubber latex"
-
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
FEN
Product Code Name
DEVICE, CYSTOMETRIC, HYDRAULIC
Public Device Record Key
20b8a87b-9dc7-47fa-afd3-0448d9aad9c1
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 01, 2016
Package DI Number
03600040196694
Quantity per Package
5
Contains DI Package
03600040196687
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 |