Duns Number:607846297
Device Description: CODMAN HAKIM Precision Fixed Pressure Valve Micro ll Valve with Unitized Ventricular and U CODMAN HAKIM Precision Fixed Pressure Valve Micro ll Valve with Unitized Ventricular and Unitized Distal Catheter Operating Pressure: 10mm H2O Plus or Minus 10mm H2O (98 Pa Plus or Minus 98 Pa) Very Low Range Includes: Precision Valve, 8.5cm Unitized Ventricular Catheter, 120cm Unitized Peritoneal Catheter, Stylet, Right Angle Adapter, Priming Adapter and Information Manual
Catalog Number
NS5116
Brand Name
CODMAN HAKIM
Version/Model Number
NS5116
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
K091346
Product Code
JXG
Product Code Name
Shunt, central nervous system and components
Public Device Record Key
df619643-7649-4cdb-818f-5480251201d8
Public Version Date
October 10, 2022
Public Version Number
6
DI Record Publish Date
September 20, 2015
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 |