DEVICE: CODMAN® HAKIM® (10381780535447)
Device Identifier (DI) Information
CODMAN® HAKIM®
NS0308
In Commercial Distribution
NS-0308
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
NS0308
In Commercial Distribution
NS-0308
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Programmable Valve with Unitized RICKHAM® Reservoir with SIPHONGUARD® Device and Unitized Clear Distal Catheter with Barium Stripe 120cm
Device Characteristics
MR Conditional | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
35965 | Cerebrospinal fluid shunt valve |
An implantable device intended to function as part of a lumboperitoneal, ventriculoperitoneal or ventriculoatrial shunt to regulate the pressure and flow level of cerebrospinal fluid (CSF) from the lumbar spine or brain to the peritoneum/heart right atrium in the management of increased intracranial pressure (e.g., caused by hydrocephalus). It consists of a mechanical valve with catheter connections and is made of synthetic polymer and/or metallic materials; it does not incorporate a port or reservoir. It typically opens at a pre-set pressure and may be non-invasively adjusted using a dedicated programmer.
|
Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
JXG | Shunt, central nervous system and components |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K221840 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Do Not Use if Package is Damaged |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
e020f63c-fafc-4fc4-9ac3-8f6f0d9ea14c
November 22, 2022
1
November 14, 2022
November 22, 2022
1
November 14, 2022
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)654-2873
custsvcnj@integralife.com
custsvcnj@integralife.com