AURORA Evacuator +Coag AEC12F/100

GUDID 00850002332216

The AURORA® Evacuator +Coag (AEC) is provided sterile, for single use only. It is a handheld, battery powered instrument that combines the ability to aspirate and break up soft tissue and fluids, apply bipolar energy for the coagulation of tissue, and apply irrigation directly to clear the surgical site, during minimally invasive surgical procedures.

REBOUND THERAPEUTICS CORPORATION

General-purpose surgical suction system, vacuum

• Primary Device ID: 00850002332216
• NIH Device Record Key: 02b18a16-7ec3-43e1-85c8-a04f543b4065
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AURORA Evacuator +Coag
• Version Model Number: AEC12F/100
• Catalog Number: AEC12F/100
• Company DUNS: 080909607
• Company Name: REBOUND THERAPEUTICS CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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
• 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
• 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
• 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
• 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

• Length: 100 Millimeter
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• Outer Diameter: 4 Millimeter
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• Outer Diameter: 4 Millimeter
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Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Keep Away From Sunlight, Do Not Use if Package is Damaged
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 500 millibar and 1050 millibar
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Keep Away From Sunlight, Do Not Use if Package is Damaged
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 500 millibar and 1050 millibar
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Keep Away From Sunlight, Do Not Use if Package is Damaged
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 500 millibar and 1050 millibar
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Keep Away From Sunlight, Do Not Use if Package is Damaged
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 500 millibar and 1050 millibar
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Keep Away From Sunlight, Do Not Use if Package is Damaged
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 500 millibar and 1050 millibar
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Keep Away From Sunlight, Do Not Use if Package is Damaged
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 500 millibar and 1050 millibar
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Keep Away From Sunlight, Do Not Use if Package is Damaged
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 500 millibar and 1050 millibar
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Keep Away From Sunlight, Do Not Use if Package is Damaged
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 500 millibar and 1050 millibar
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Keep Away From Sunlight, Do Not Use if Package is Damaged
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 500 millibar and 1050 millibar
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Keep Away From Sunlight, Do Not Use if Package is Damaged
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 500 millibar and 1050 millibar
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Keep Away From Sunlight, Do Not Use if Package is Damaged
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 500 millibar and 1050 millibar
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Keep Away From Sunlight, Do Not Use if Package is Damaged
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 500 millibar and 1050 millibar
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Keep Away From Sunlight, Do Not Use if Package is Damaged
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 500 millibar and 1050 millibar
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Keep Away From Sunlight, Do Not Use if Package is Damaged
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 500 millibar and 1050 millibar
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850002332216 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201637
• Premarket Notification: K203745

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

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: 2021-01-20
• Device Publish Date: 2021-01-12

On-Brand Devices [AURORA Evacuator +Coag]

• 00850002332223: The AURORA® Evacuator +Coag (AEC) is provided sterile, for single use only. It is a handheld,
• 00850002332216: The AURORA® Evacuator +Coag (AEC) is provided sterile, for single use only. It is a handheld,
• 00850002332209: The AURORA® Evacuator +Coag (AEC) is provided sterile, for single use only. It is a handheld,