Duns Number:203383526
Catalog Number
-
Brand Name
Catheter, Pabd, Dual Lumen, Closed Balloon, Silicone, 12Fr
Version/Model Number
CATW1A212EB
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)
-
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
e029bfc4-44eb-4aea-917c-14ee75239e4a
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
October 01, 2017
Package DI Number
20627825010447
Quantity per Package
10
Contains DI Package
10627825010440
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 258 |