Duns Number:607846297
Device Description: CODMAN EDS 3 CSF External Drainage System with Ventricular Catheter (REF 82-1735) Clear Ve CODMAN EDS 3 CSF External Drainage System with Ventricular Catheter (REF 82-1735) Clear Ventricular CSF Catheter Includes 35cm Ventricular Catheter, Stylet, Connector, Cap and Trocar
Catalog Number
821730C
Brand Name
CODMAN EDS 3
Version/Model Number
82-1730C
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 01, 2022
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
K172537
Product Code
JXG
Product Code Name
Shunt, central nervous system and components
Public Device Record Key
d975eaca-9a8d-4623-951c-03dd2a2edd4e
Public Version Date
September 01, 2022
Public Version Number
3
DI Record Publish Date
August 17, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 40 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1054 |
| 3 | A medical device with high risk that requires premarket approval | 11 |