Aurora® Surgiscope® ASX9/100

GUDID 00850002332285

Aurora® Surgiscope® System

Integra Lifesciences Corporation

Rigid optical intracranial/spinal endoscope, single-use Rigid optical intracranial/spinal endoscope, single-use Rigid optical intracranial/spinal endoscope, single-use Rigid optical intracranial/spinal endoscope, single-use Rigid optical intracranial/spinal endoscope, single-use Rigid optical intracranial/spinal endoscope, single-use Rigid optical intracranial/spinal endoscope, single-use Rigid optical intracranial/spinal endoscope, single-use Rigid optical intracranial/spinal endoscope, single-use Rigid optical intracranial/spinal endoscope, single-use Rigid optical intracranial/spinal endoscope, single-use Rigid optical intracranial/spinal endoscope, single-use Rigid optical intracranial/spinal endoscope, single-use Rigid optical intracranial/spinal endoscope, single-use Rigid optical intracranial/spinal endoscope, single-use Rigid optical intracranial/spinal endoscope, single-use Rigid optical intracranial/spinal endoscope, single-use

• Primary Device ID: 00850002332285
• NIH Device Record Key: 1faa8ea8-c4b3-4629-aef0-e61a1698eea6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aurora® Surgiscope®
• Version Model Number: ASX9/100
• Catalog Number: ASX9/100
• Company DUNS: 083171244
• Company Name: Integra Lifesciences Corporation
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 697 millibar and 1010 millibar
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 697 millibar and 1010 millibar
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 697 millibar and 1010 millibar
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 697 millibar and 1010 millibar
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 697 millibar and 1010 millibar
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 697 millibar and 1010 millibar
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 697 millibar and 1010 millibar
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 697 millibar and 1010 millibar
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 697 millibar and 1010 millibar
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 697 millibar and 1010 millibar
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 697 millibar and 1010 millibar
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 697 millibar and 1010 millibar
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 697 millibar and 1010 millibar
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 697 millibar and 1010 millibar
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 697 millibar and 1010 millibar
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 697 millibar and 1010 millibar
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 697 millibar and 1010 millibar
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850002332285 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232618

FDA Product Code

• GZT: RETRACTOR, SELF-RETAINING, FOR NEUROSURGERY

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: 2023-11-17
• Device Publish Date: 2023-11-09

On-Brand Devices [Aurora® Surgiscope®]

• 00850002332292: Aurora® Surgiscope® System
• 00850002332285: Aurora® Surgiscope® System
• 00850002332278: Aurora® Surgiscope® System