AURORA® ICB/PC

GUDID 00850002332049

Surgiscope® System Power Cable

REBOUND THERAPEUTICS CORPORATION

Endoscopic video image processing unit

• Primary Device ID: 00850002332049
• NIH Device Record Key: 73384541-c767-4519-8f93-c65313f54890
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AURORA®
• Version Model Number: ICB/PC
• Catalog Number: ICB/PC
• Company DUNS: 080909607
• Company Name: REBOUND THERAPEUTICS 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• 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

Operating and Storage Conditions

• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 697 millibar and 1010 millibar
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep Dry. Do Not Use if Package is Damaged
• Handling Environment Temperature: Between 29 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850002332049 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201840

FDA Product Code

• GWG: Endoscope, neurological

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-12-07
• Device Publish Date: 2022-11-29

Devices Manufactured by REBOUND THERAPEUTICS CORPORATION

• 00850002332049 - AURORA®: 2022-12-07Surgiscope® System Power Cable
• 00850002332049 - AURORA®: 2022-12-07 Surgiscope® System Power Cable
• 00850002332247 - Aurora Surgiscope System: 2021-05-26 The AURORA Surgiscope System consists of two components: sterile, single use, neurological endoscope called the AURORA Surgisco
• 00850002332254 - Aurora Surgiscope System: 2021-05-26 The AURORA Surgiscope System consists of two components: sterile, single use, neurological endoscope called the AURORA Surgisco
• 00850002332261 - Aurora Surgiscope System: 2021-05-26 The Image Control Box (ICB) provides power to the AURORA Surgiscope, transfers the video to a Display Monitor, and allows the us
• 00850002332209 - AURORA Evacuator +Coag: 2021-01-20 The AURORA® Evacuator +Coag (AEC) is provided sterile, for single use only. It is a handheld, battery powered instrument that
• 00850002332216 - AURORA Evacuator +Coag: 2021-01-20 The AURORA® Evacuator +Coag (AEC) is provided sterile, for single use only. It is a handheld, battery powered instrument that
• 00850002332223 - AURORA Evacuator +Coag: 2021-01-20 The AURORA® Evacuator +Coag (AEC) is provided sterile, for single use only. It is a handheld, battery powered instrument that
• 00850002332148 - AURORA Evacuator: 2020-02-14 The Aurora EVACUATOR is provided sterile, for single-use only. It is a disposable, handheld, aspiration device designed to remov