Duns Number:002348191
Device Description: TAUT CHOLANGIOGRAPHY CATHETER 10/BOX 4.5 FRENCH X 18"
Catalog Number
965500
Brand Name
TAUT
Version/Model Number
IPN010493
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"
-
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
GBZ
Product Code Name
CATHETER, CHOLANGIOGRAPHY
Public Device Record Key
5c2d4c3e-739f-4844-a680-388dea47d5c2
Public Version Date
September 09, 2020
Public Version Number
2
DI Record Publish Date
September 15, 2018
Package DI Number
44026704418938
Quantity per Package
10
Contains DI Package
24026704418934
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3195 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 13747 |
| 3 | A medical device with high risk that requires premarket approval | 3 |
| U | Unclassified | 26 |