HAKIM® 82-3028

GUDID 10381780518730

Micro Valve, Operating Pressure: 70mm H2O ± 10mm H2O (686 Pa ± 98 Pa) Medium 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 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 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 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 ID10381780518730
NIH Device Record Keyc7ad711e-dda6-4cb1-9e91-6fdb37c4e571
Commercial Distribution StatusIn Commercial Distribution
Brand NameHAKIM®
Version Model Number823028
Catalog Number82-3028
Company DUNS081277700
Company NameINTEGRA LIFESCIENCES PRODUCTION CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged

Device Identifiers

Device Issuing AgencyDevice ID
GS110381780518730 [Primary]
GS110381780534273 [Primary]
GS110886704041177 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JXGShunt, central nervous system and components

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2021-04-07
Device Publish Date2020-06-02

On-Brand Devices [HAKIM®]

10381780526797Shunt System Clear with Barium Stripe Peritoneal Catheter 120cm, with Drainage Holes and Marking
10381780525172Shunt System Clear with Barium Stripe 15cm Ventricular Catheter with Centimeter Markings Include
10381780519317Valve Programmer, 100-240V, IEC NOTICE: Do not exceed the following transport and storage condit
10381780525097Micro II Valve, 30mm H2O to 200mm H2O, Programmable in steps of 10mm
10381780520238Right Angle Valve, Operating Pressure: 100mm H2O ± 10mm H2O (980 Pa ± 98 Pa) Medium High Rang
10381780520221Right Angle Valve, Operating Pressure: 70mm H2O ± 10mm H2O (686 Pa ± 98 Pa) Medium Low Range
10381780520214Right Angle Valve, Operating Pressure: 40mm H2O ± 10mm H2O (392 Pa ± 98 Pa) Low Range
10381780520207Right Angle Valve, Operating Pressure: 10mm H2O ± 10mm H2O (98 Pa ± 98 Pa) Very Low Range
10381780520146In-Line Valve, Operating Pressure: 130mm H2O ± 10mm H2O (1274 Pa ± 98 Pa) High Range
10381780520122In-Line Valve, Operating Pressure: 70mm H2O ± 10mm H2O (686 Pa ± 98 Pa) Medium Low Range
10381780520108In-Line Valve, Operating Pressure: 10mm H2O ± 10mm H2O (98 Pa ± 98 Pa) Very Low Range
10381780519188Cylindrical Valve
10381780519133Cylindrical Valve with Prechamber
10381780519003Cylindrical Valve, Operating Pressure: 100mm H2O ± 10mm H2O (980 Pa ± 98 Pa) Medium High Rang
10381780518747Micro Valve, Operating Pressure: 100mm H2O ± 10mm H2O (980 Pa ± 98 Pa) Medium High Range
10381780518730Micro Valve, Operating Pressure: 70mm H2O ± 10mm H2O (686 Pa ± 98 Pa) Medium Low Range
10381780518723Micro Valve, Operating Pressure: 40mm H2O ± 10mm H2O (392 Pa ± 98 Pa) Low Range
10381780518594Cylindrical Valve with Prechamber, Operating Pressure: 100mm H2O ± 10mm H2O (980 Pa ± 98 Pa)
10381780518587Cylindrical Valve with Prechamber, Operating Pressure: 70mm H2O ± 10mm H2O (686 Pa ± 98 Pa) M
10381780518570Cylindrical Valve with Prechamber, Operating Pressure: 40mm H2O ± 10mm H2O (392 Pa ± 98 Pa) L
10381780519171Micro Valve and Unitized Distal Catheter
10381780518792Micro Valve and Unitized Distal Catheter, Operating Pressure: 100mm H2O ± 10mm H2O (980 Pa ±
10381780518778Micro Valve and Unitized Distal Catheter, Operating Pressure: 40mm H2O ± 10mm H2O (392 Pa ± 9
10381780519829Right Angle Valve
10381780519645In-Line Valve and Unitized Distal Catheter, Operating Pressure: 130mm H2O ± 10mm H2O (1274 Pa
10381780519638In-Line Valve and Unitized Distal Catheter, Operating Pressure: 100mm H2O ± 10mm H2O (980 Pa �
10381780519621In-Line Valve and Unitized Distal Catheter, Operating Pressure: 70mm H2O ± 10mm H2O (686 Pa ±
10381780519614In-Line Valve and Unitized Distal Catheter, Operating Pressure: 40mm H2O ± 10mm H2O (392 Pa ±
10381780519140Cylindrical Valve with Prechamber and Unitized Distal Catheter
10381780518785Micro Valve and Unitized Distal Catheter, Operating Pressure: 70mm H2O ± 10mm H2O (686 Pa ± 9
10381780518549Cylindrical Valve with Prechamber and Unitized Distal Catheter, Operating Pressure: 100mm H2O �

Trademark Results [HAKIM]

Mark Image

Registration | Serial
Company
Trademark
Application Date
HAKIM
HAKIM
88060571 not registered Live/Pending
Shanghai Jiani Trading Co., ltd
2018-08-01
HAKIM
HAKIM
74800604 2109618 Live/Registered
HAKIM USA, LLC
1989-11-28
HAKIM
HAKIM
74005786 2029413 Live/Registered
MEDOS S.A.
1989-11-28

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