Duns Number:607846297
Device Description: CODMAN HAKIM Valve Programmer, 100-240V, IEC NOTICE: Do not exceed the following transport CODMAN HAKIM Valve Programmer, 100-240V, IEC NOTICE: Do not exceed the following transport and storage conditions. Temperature -40 DEGREES C - +60 DEGREES C Relative Humidity 10 Percent - 85 Percent Atmospheric Pressure 500hPa - 1060hPa
Catalog Number
823190R
Brand Name
CODMAN HAKIM
Version/Model Number
823190R
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
-
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
K003564
Product Code
JXG
Product Code Name
Shunt, central nervous system and components
Public Device Record Key
f7661544-5077-4279-80af-ff40c1adfe17
Public Version Date
September 01, 2022
Public Version Number
4
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 |