Duns Number:081277700
Device Description: Cylindrical, Integral Connectors and Unitized Rickham Reservoir, 30mm H2O to 200mm H2O, Pr Cylindrical, Integral Connectors and Unitized Rickham Reservoir, 30mm H2O to 200mm H2O, Programmable in steps of 10mm
Catalog Number
NS5113
Brand Name
CODMAN® HAKIM®
Version/Model Number
NS5113
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
K020667,K020667
Product Code
JXG
Product Code Name
Shunt, central nervous system and components
Public Device Record Key
63f829d6-cce6-4414-9c1f-ef0b28229f92
Public Version Date
October 26, 2022
Public Version Number
3
DI Record Publish Date
June 02, 2020
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 | 15051 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4286 |
| 3 | A medical device with high risk that requires premarket approval | 2 |
| U | Unclassified | 3 |