DirectLink™ 82-6828

GUDID 10381780538349

DirectLink™ ICP Module

Integra LifeSciences Switzerland Sàrl

Intracranial pressure monitor
Primary Device ID10381780538349
NIH Device Record Key6ff2bfc8-b39a-4e5a-8a21-5747b11138e4
Commercial Distribution StatusIn Commercial Distribution
Brand NameDirectLink™
Version Model Number826828
Catalog Number82-6828
Company DUNS480186617
Company NameIntegra LifeSciences Switzerland Sàrl
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
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

Operating and Storage Conditions

Handling Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Waste Electrical and Electronic Equipment
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Waste Electrical and Electronic Equipment
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Waste Electrical and Electronic Equipment
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Waste Electrical and Electronic Equipment
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Waste Electrical and Electronic Equipment
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Waste Electrical and Electronic Equipment
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Waste Electrical and Electronic Equipment
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Waste Electrical and Electronic Equipment
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Waste Electrical and Electronic Equipment
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Waste Electrical and Electronic Equipment
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Waste Electrical and Electronic Equipment
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Waste Electrical and Electronic Equipment
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Waste Electrical and Electronic Equipment
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Waste Electrical and Electronic Equipment
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Waste Electrical and Electronic Equipment
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Waste Electrical and Electronic Equipment
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Waste Electrical and Electronic Equipment
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS110381780515784 [Previous]
GS110381780538349 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GWMDevice, monitoring, intracranial pressure

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-07-08
Device Publish Date2024-06-28

Devices Manufactured by Integra LifeSciences Switzerland Sàrl

10381780538349 - DirectLink™2024-07-08DirectLink™ ICP Module
10381780538349 - DirectLink™2024-07-08 DirectLink™ ICP Module
M2727CBD101 - NeuroBalloon™2022-09-14 Catheter
10381780034407 - Tuohy Needle2022-08-22 The Integra 14G thin wall Tuohy Needle is a single use instrument consisting of a stainless steel cannula, obturator and winged
M272IM11 - Licox ®2022-08-22 Licox® IM1 Single Lumen Introducer Kit is used to insert the Licox® Oxygen probe. It contains: Single lumen Introducer, Guidew
M272IP11 - Licox ®2022-08-22 Licox® IP1 Single Lumen Introducer Kit is used to insert the combined oxygen/temperature probe. It contains: Single lumen Intro
M272IP21 - Licox ®2022-08-22 Licox® IP2 Dual Lumen Introducer Kit contains is used to insert the combined oxygen/temperature probe and the ICP Catheter. It
10886704079910 - CODMAN®2021-09-22 Standard Disposable Non-Stick Bipolar Forceps
10886704079927 - CODMAN®2021-09-22 Standard Disposable Non-Stick Bipolar Forceps

Trademark Results [DirectLink]

Mark Image

Registration | Serial
Company
Trademark
Application Date
DIRECTLINK
DIRECTLINK
98273593 not registered Live/Pending
Waldemar Link GmbH & Co. KG
2023-11-16
DIRECTLINK
DIRECTLINK
88764484 not registered Live/Pending
Canby Telephone Association
2020-01-17
DIRECTLINK
DIRECTLINK
88764478 not registered Live/Pending
Canby Telephone Association
2020-01-17
DIRECTLINK
DIRECTLINK
87553272 5442628 Live/Registered
DirectLink, LLC
2017-08-02
DIRECTLINK
DIRECTLINK
86722077 5167295 Live/Registered
INTEGRA LIFESCIENCES CORPORATION
2015-08-12
DIRECTLINK
DIRECTLINK
78943263 3390221 Live/Registered
Directlink Technologies Corporation
2006-08-02
DIRECTLINK
DIRECTLINK
78731599 3139117 Dead/Cancelled
Unicontrol Inc.
2005-10-12
DIRECTLINK
DIRECTLINK
78428071 not registered Dead/Abandoned
Direct Response Technologies, Inc.
2004-06-01
DIRECTLINK
DIRECTLINK
77901837 3827930 Dead/Cancelled
Directlink, LLC
2009-12-29
DIRECTLINK
DIRECTLINK
76415623 not registered Dead/Abandoned
Uniden America Corporation
2002-06-04
DIRECTLINK
DIRECTLINK
75448601 2501183 Dead/Cancelled
LASALLE BANK CORPORATION
1998-03-11
DIRECTLINK
DIRECTLINK
75301685 not registered Dead/Abandoned
Pennsylvania Higher Education Assistance Agency
1997-06-02

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