Duns Number:607846297
Device Description: CODMAN MICROSENSOR Ventricular Catheter Kit With ICP Sensor Contains (1) Microsensor Ventr CODMAN MICROSENSOR Ventricular Catheter Kit With ICP Sensor Contains (1) Microsensor Ventricular Catheter, (1) Tunneling Trocar, (1) Catheter Anchoring Clip
Catalog Number
826653
Brand Name
CODMAN MICROSENSOR
Version/Model Number
82-6653
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
K991222
Product Code
GWM
Product Code Name
DEVICE, MONITORING, INTRACRANIAL PRESSURE
Public Device Record Key
f4dc715c-8774-43d6-a612-5ec893a73e23
Public Version Date
September 01, 2022
Public Version Number
7
DI Record Publish Date
June 30, 2016
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 |