Aurora® Surgiscope® ASX9/130

GUDID 00850002332278

Aurora® Surgiscope® System

Integra Lifesciences Corporation

Rigid optical intracranial/spinal endoscope, single-use
Primary Device ID00850002332278
NIH Device Record Keybcca08a4-b8e7-4142-bc3d-39026edc9e3b
Commercial Distribution StatusIn Commercial Distribution
Brand NameAurora® Surgiscope®
Version Model NumberASX9/130
Catalog NumberASX9/130
Company DUNS083171244
Company NameIntegra Lifesciences Corporation
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
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

Device Dimensions

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Operating and Storage Conditions

Storage Environment Atmospheric PressureBetween 697 millibar and 1010 millibar
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep dry
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 697 millibar and 1010 millibar
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep dry
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 697 millibar and 1010 millibar
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep dry
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 697 millibar and 1010 millibar
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep dry
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 697 millibar and 1010 millibar
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep dry
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 697 millibar and 1010 millibar
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep dry
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 697 millibar and 1010 millibar
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep dry
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 697 millibar and 1010 millibar
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep dry
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 697 millibar and 1010 millibar
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep dry
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 697 millibar and 1010 millibar
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep dry
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 697 millibar and 1010 millibar
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep dry
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 697 millibar and 1010 millibar
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep dry
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 697 millibar and 1010 millibar
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep dry
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 697 millibar and 1010 millibar
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep dry
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 697 millibar and 1010 millibar
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep dry
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 697 millibar and 1010 millibar
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep dry
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 697 millibar and 1010 millibar
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep dry
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Fahrenheit and 140 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100850002332278 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GWGEndoscope, neurological

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-17
Device Publish Date2023-11-09

On-Brand Devices [Aurora® Surgiscope®]

00850002332292Aurora® Surgiscope® System
00850002332285Aurora® Surgiscope® System
00850002332278Aurora® Surgiscope® System

Trademark Results [Aurora]

Mark Image

Registration | Serial
Company
Trademark
Application Date
AURORA
AURORA
98871520 not registered Live/Pending
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2024-11-25
AURORA
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2024-11-14
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COOPERATIVA CENTRAL AURORA ALIMENTOS
2024-11-12
AURORA
AURORA
98633708 not registered Live/Pending
Lishui Longyiren Equipment Co., Ltd.
2024-07-04
AURORA
AURORA
98630900 not registered Live/Pending
Aurora Outdoors LLC
2024-07-03
AURORA
AURORA
98599374 not registered Live/Pending
Racemasters, Inc.
2024-06-13
AURORA
AURORA
98594731 not registered Live/Pending
Shared Plate Hospitality, LLC
2024-06-11
AURORA
AURORA
98544467 not registered Live/Pending
Native Instruments USA, Inc.
2024-05-10
AURORA
AURORA
98537546 not registered Live/Pending
Paulo Cesar Ferreira
2024-05-07
AURORA
AURORA
98484669 not registered Live/Pending
Teal Communications, Inc.
2024-04-04
AURORA
AURORA
98447552 not registered Live/Pending
Praesto LLC
2024-03-13
AURORA
AURORA
98393802 not registered Live/Pending
Strings by Aurora
2024-02-06

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