HAKIM® 82-3111
GUDID 10381780519140
Cylindrical Valve with Prechamber and Unitized Distal Catheter
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Ventriculoperitoneal shunt| Primary Device ID | 10381780519140 |
| NIH Device Record Key | 7c9eec34-8b0c-4a36-93a8-ddf00af486c1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HAKIM® |
| Version Model Number | 823111 |
| Catalog Number | 82-3111 |
| 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 | |
| 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 |
| 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 | 10381780519140 [Primary] |
| GS1 | 10886704041467 [Previous] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K122118
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 | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2022-10-03 |
| Device Publish Date | 2020-06-02 |
On-Brand Devices [HAKIM®]
| 10381780526797 | Shunt System Clear with Barium Stripe Peritoneal Catheter 120cm, with Drainage Holes and Marking |
| 10381780525172 | Shunt System Clear with Barium Stripe 15cm Ventricular Catheter with Centimeter Markings Include |
| 10381780519317 | Valve Programmer, 100-240V, IEC NOTICE: Do not exceed the following transport and storage condit |
| 10381780525097 | Micro II Valve, 30mm H2O to 200mm H2O, Programmable in steps of 10mm |
| 10381780520238 | Right Angle Valve, Operating Pressure: 100mm H2O ± 10mm H2O (980 Pa ± 98 Pa) Medium High Rang |
| 10381780520221 | Right Angle Valve, Operating Pressure: 70mm H2O ± 10mm H2O (686 Pa ± 98 Pa) Medium Low Range |
| 10381780520214 | Right Angle Valve, Operating Pressure: 40mm H2O ± 10mm H2O (392 Pa ± 98 Pa) Low Range |
| 10381780520207 | Right Angle Valve, Operating Pressure: 10mm H2O ± 10mm H2O (98 Pa ± 98 Pa) Very Low Range |
| 10381780520146 | In-Line Valve, Operating Pressure: 130mm H2O ± 10mm H2O (1274 Pa ± 98 Pa) High Range |
| 10381780520122 | In-Line Valve, Operating Pressure: 70mm H2O ± 10mm H2O (686 Pa ± 98 Pa) Medium Low Range |
| 10381780520108 | In-Line Valve, Operating Pressure: 10mm H2O ± 10mm H2O (98 Pa ± 98 Pa) Very Low Range |
| 10381780519188 | Cylindrical Valve |
| 10381780519133 | Cylindrical Valve with Prechamber |
| 10381780519003 | Cylindrical Valve, Operating Pressure: 100mm H2O ± 10mm H2O (980 Pa ± 98 Pa) Medium High Rang |
| 10381780518747 | Micro Valve, Operating Pressure: 100mm H2O ± 10mm H2O (980 Pa ± 98 Pa) Medium High Range |
| 10381780518730 | Micro Valve, Operating Pressure: 70mm H2O ± 10mm H2O (686 Pa ± 98 Pa) Medium Low Range |
| 10381780518723 | Micro Valve, Operating Pressure: 40mm H2O ± 10mm H2O (392 Pa ± 98 Pa) Low Range |
| 10381780518594 | Cylindrical Valve with Prechamber, Operating Pressure: 100mm H2O ± 10mm H2O (980 Pa ± 98 Pa) |
| 10381780518587 | Cylindrical Valve with Prechamber, Operating Pressure: 70mm H2O ± 10mm H2O (686 Pa ± 98 Pa) M |
| 10381780518570 | Cylindrical Valve with Prechamber, Operating Pressure: 40mm H2O ± 10mm H2O (392 Pa ± 98 Pa) L |
| 10381780519171 | Micro Valve and Unitized Distal Catheter |
| 10381780518792 | Micro Valve and Unitized Distal Catheter, Operating Pressure: 100mm H2O ± 10mm H2O (980 Pa ± |
| 10381780518778 | Micro Valve and Unitized Distal Catheter, Operating Pressure: 40mm H2O ± 10mm H2O (392 Pa ± 9 |
| 10381780519829 | Right Angle Valve |
| 10381780519645 | In-Line Valve and Unitized Distal Catheter, Operating Pressure: 130mm H2O ± 10mm H2O (1274 Pa |
| 10381780519638 | In-Line Valve and Unitized Distal Catheter, Operating Pressure: 100mm H2O ± 10mm H2O (980 Pa  |
| 10381780519621 | In-Line Valve and Unitized Distal Catheter, Operating Pressure: 70mm H2O ± 10mm H2O (686 Pa ± |
| 10381780519614 | In-Line Valve and Unitized Distal Catheter, Operating Pressure: 40mm H2O ± 10mm H2O (392 Pa ± |
| 10381780519140 | Cylindrical Valve with Prechamber and Unitized Distal Catheter |
| 10381780518785 | Micro Valve and Unitized Distal Catheter, Operating Pressure: 70mm H2O ± 10mm H2O (686 Pa ± 9 |
| 10381780518549 | Cylindrical Valve with Prechamber and Unitized Distal Catheter, Operating Pressure: 100mm H2O Â |
Trademark Results [HAKIM]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HAKIM 88060571 not registered Live/Pending |
Shanghai Jiani Trading Co., ltd 2018-08-01 |
 HAKIM 74800604 2109618 Live/Registered |
HAKIM USA, LLC 1989-11-28 |
 HAKIM 74005786 2029413 Live/Registered |
MEDOS S.A. 1989-11-28 |
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