Duns Number:809699023
Device Description: 8F x 20cm J-Tip Multipurpose Drainage Catheter with GLYCE Hydrophilic Coating
Catalog Number
-
Brand Name
Exodus
Version/Model Number
10001
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 12, 2021
Issuing Agency
In HIBCC
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
FGE
Product Code Name
CATHETER, BILIARY, DIAGNOSTIC
Public Device Record Key
9a8bbbb8-7317-4e46-b35f-0beb2f62dd8e
Public Version Date
March 08, 2022
Public Version Number
4
DI Record Publish Date
September 11, 2015
Package DI Number
H965100011
Quantity per Package
5
Contains DI Package
H965100010
Package Discontinue Date
August 12, 2021
Package Status
Not in Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 71 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1641 |