CODMAN® HAKIM® 82-3007
GUDID 10381780534068
Precision Fixed Pressure Valve Cylindrical Valve with Prechamber and Unitized Distal Catheter Low Range
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Cerebrospinal fluid shunt valve Cerebrospinal fluid shunt valve Cerebrospinal fluid shunt valve Cerebrospinal fluid shunt valve Cerebrospinal fluid shunt valve Cerebrospinal fluid shunt valve Cerebrospinal fluid shunt valve Cerebrospinal fluid shunt valve Cerebrospinal fluid shunt valve Cerebrospinal fluid shunt valve Cerebrospinal fluid shunt valve Cerebrospinal fluid shunt valve Cerebrospinal fluid shunt valve Cerebrospinal fluid shunt valve Cerebrospinal fluid shunt valve Cerebrospinal fluid shunt valve| Primary Device ID | 10381780534068 |
| NIH Device Record Key | f99610c3-cb12-487c-9ac4-e472acf51d56 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CODMAN® HAKIM® |
| Version Model Number | 823007 |
| Catalog Number | 82-3007 |
| 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 | 10381780518525 [Previous] |
| GS1 | 10381780534068 [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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