Duns Number:192559557
Device Description: HYDROPHILIC COATED BILIARY LOCKING CATHETER WITH RADIOPAQUE MARKER, DEPTH MARKS, AND EXTRA HYDROPHILIC COATED BILIARY LOCKING CATHETER WITH RADIOPAQUE MARKER, DEPTH MARKS, AND EXTRA HOLES, 8F
Catalog Number
CCL2-0850HBX
Brand Name
Chole-Cath Biliary Drainage Catheter
Version/Model Number
CCL2-0850HBX
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
K923096,K923096,K923096
Product Code
FGE
Product Code Name
Catheter, Biliary, Diagnostic
Public Device Record Key
988981f1-c690-443d-96db-c78b14c52ca5
Public Version Date
May 06, 2022
Public Version Number
1
DI Record Publish Date
April 28, 2022
Package DI Number
10817640021145
Quantity per Package
5
Contains DI Package
00817640021148
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Dispenser
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 179 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 77 |
| U | Unclassified | 24 |