Duns Number:607846297
Device Description: CODMAN HAKIM Programmable Valve In-Line Valve Only, .030 Inch Reinforced Platform Operatin
Catalog Number
NS5045
Brand Name
CODMAN HAKIM
Version/Model Number
NS5045
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
K053350
Product Code
JXG
Product Code Name
Shunt, central nervous system and components
Public Device Record Key
6360c610-7282-440a-9999-74bb93807b41
Public Version Date
September 01, 2022
Public Version Number
5
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 |