Duns Number:607846297
Device Description: CODMAN Lumbar Catheter Kit II (82-1707) with EDS 3 CSF External Drainage System (82-1731C)
Catalog Number
821738C
Brand Name
CODMAN EDS 3
Version/Model Number
82-1738C
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 01, 2022
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
K172537
Product Code
JXG
Product Code Name
Shunt, central nervous system and components
Public Device Record Key
9ef8a81f-e376-4527-b01d-8ab0ce8a2448
Public Version Date
September 01, 2022
Public Version Number
3
DI Record Publish Date
September 11, 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 |