CODMAN® HAKIM® 82-5492
GUDID 10381780535324
Precision Fixed Pressure Valve Right Angle Valve Low Range
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Cerebrospinal fluid shunt valve| Primary Device ID | 10381780535324 |
| NIH Device Record Key | 9927e6a9-5522-40b5-b49b-0172b6a6b39c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CODMAN® HAKIM® |
| Version Model Number | 825492 |
| Catalog Number | 82-5492 |
| Company DUNS | 081277700 |
| Company Name | INTEGRA LIFESCIENCES PRODUCTION CORPORATION |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10381780520214 [Previous] |
| GS1 | 10381780535324 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K221840
FDA Product Code
| JXG | Shunt, central nervous system and components |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-11-22 |
| Device Publish Date | 2022-11-14 |
On-Brand Devices [CODMAN® HAKIM®]
| 10381780535751 | Programmable Cylindrical Valve with Integral Connectors and Unitized Richham Reservoir |
| 10381780535744 | Programmable Valve Cylindrical Valve with Proximal Connector and Unitized Barium Distal Catheter |
| 10381780535737 | Programmable Valve with Unitized RICKHAM® Reservoir and Unitized SIPHONGUARD® Device |
| 10381780535720 | Programmable Valve In-Line Valve with SIPHONGUARD® and .060" Platform |
| 10381780535713 | Programmable Valve In-Line Valve Only, .030" Reinforced Platform |
| 10381780535690 | Programmable Valve Cylindrical Valve with Integral Connectors |
| 10381780535683 | Programmable Valve Micro II Valve |
| 10381780535676 | Programmable Valve Micro 11 Valve, with SIPHONGUARD® and Unitized SALMON-RICKHAM® Reservoir (P |
| 10381780535560 | Programmable Valve In-Line Valve with SIPHONGUARD® Device and .030" Reinforced Platform |
| 10381780535553 | Programmable Cylindrical Valve with Large Rickham Reservoir |
| 10381780535485 | Programmable Cylindrical Valve with Rickham Reservoir and Unitized SIPHONGUARD® Device and Dist |
| 10381780524182 | Programmable Valve Micro II Valve with RICKHAM® Reservoir and SIPHONGUARD® Device |
| 10381780535461 | Programmable Micro Valve with Unitized RICKHAM® Reservoir with 2cm Arm (Metal Base) |
| 10381780535447 | Programmable Valve with Unitized RICKHAM® Reservoir with SIPHONGUARD® Device and Unitized Clea |
| 10381780535355 | Precision Fixed Pressure Valve Right Angle Valve High Range |
| 10381780535348 | Precision Fixed Pressure Valve Right Angle Valve Medium High Range |
| 10381780535324 | Precision Fixed Pressure Valve Right Angle Valve Low Range |
| 10381780535317 | Precision Fixed Pressure Valve Right Angle Valve Very Low Range |
| 10381780520184 | Precision Fixed Pressure Valve Right Angle Valve with SIPHONGUARD® Device Medium High Range |
| 10381780535263 | Precision Fixed Pressure Valve Right Angle Valve with SIPHONGUARD® Device Very Low Range |
| 10381780535249 | Precision Fixed Pressure Valve In-Line Valve Medium High Range |
| 10381780535232 | Precision Fixed Pressure Valve In-Line Valve Medium Range |
| 10381780520115 | Precision Fixed Pressure Valve In-Line Valve Low Range |
| 10381780535218 | Precision Fixed Pressure Valve In-Line Valve Very Low Range |
| 10381780535201 | Precision Fixed Pressure Valve In-Line Valve with SIPHONGUARD® Device High Range |
| 10381780535195 | Precision Fixed Pressure Valve In-Line Valve with SIPHONGUARD® Device Medium High Range |
| 10381780535188 | Precision Fixed Pressure Valve In-Line Valve with SIPHONGUARD® Device Medium Range |
| 10381780535171 | Precision Fixed Pressure Valve In-Line Valve with SIPHONGUARD® Device Low Range |
| 10381780535164 | Precision Fixed Pressure Valve In-Line Valve with SIPHONGUARD® Device Very Low Range |
| 10381780535126 | Programmable Valve Cylindrical valve with Unitized RICKHAM® Reservoir and Non- Unitized Distal |
| 10381780535096 | Programmable Valve Cylindrical valve with Unitized Large RICKHAM® Reservoir and Non-Unitized Di |
| 10381780535089 | Programmable Valve Cylindrical valve with Unitized RICKHAM® Reservoir and Unitized Distal Cathe |
| 10381780519843 | Programmable Valve In-line Valve and Unitized Distal Catheter |
| 10381780535065 | Programmable Valve In-line Valve with SIPHONGUARD™ Device and Unitized Distal Catheter |
| 10381780535058 | Programmable Valve Right Angle Valve |
| 10381780535041 | Programmable Valve In-line Valve |
| 10381780535034 | Programmable Valve In-line Valve with SIPHONGUARD™ Device |
| 10381780535027 | Precision Fixed Pressure Valve In-Line Valve with SIPHONGUARD® Device High Range |
| 10381780535010 | Precision Fixed Pressure Valve In-Line Valve with SIPHONGUARD® Device and Unitized Catheter Hig |
| 10381780534990 | Precision Fixed Pressure Valve In-Line Valve with SIPHONGUARD® Device and Unitized Catheter Low |
| 10381780534983 | Precision Fixed Pressure Valve In-Line Valve with SIPHONGUARD® Device and Unitized Distal Cathe |
| 10381780534877 | Precision Fixed Pressure Valve In-Line Valve and Unitized Distal Catheter High Range |
| 10381780519607 | Precision Fixed Pressure Valve In-Line Valve and Unitized Distal Catheter Very Low Range |
| 10381780534730 | Precision Fixed Pressure Valve Right Angle Valve and Unitized Distal Catheter High Range |
| 10381780534723 | Precision Fixed Pressure Valve Right Angle Valve and Unitized Distal Catheter Medium High Range |
| 10381780519461 | Precision Fixed Pressure Valve Right Angle Valve and Unitized Distal Catheter Medium Range |
| 10381780519454 | Precision Fixed Pressure Valve Right Angle Valve and Unitized Distal Catheter Low Range |
| 10381780534693 | Precision Fixed Pressure Valve Right Angle Valve and Unitized Distal Catheter Very Low Range |
| 10381780534686 | Precision Fixed Pressure Valve Right Angle Valve with SIPHONGUARD® Device Unitized Distal Cathe |
| 10381780519423 | Precision Fixed Pressure Valve Right Angle Valve with SIPHONGUARD® Device Unitized Distal Cathe |
Trademark Results [CODMAN]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CODMAN 72381672 0917323 Live/Registered |
JOHNSON & JOHNSON 1971-02-18 |
 CODMAN 72381347 0925169 Live/Registered |
JOHNSON & JOHNSON 1971-02-11 |
 CODMAN 72258343 0840934 Live/Registered |
CODMAN & SHURTLEFF, INC. 1966-11-10 |
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