AURORA Evacuator +Coag AEC12F/70

GUDID 00850002332223

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 ID00850002332223
NIH Device Record Keyf7a3f812-da93-4477-bf79-8ee5f08bb3e8
Commercial Distribution StatusIn Commercial Distribution
Brand NameAURORA Evacuator +Coag
Version Model NumberAEC12F/70
Catalog NumberAEC12F/70
Company DUNS080909607
Company NameREBOUND THERAPEUTICS CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
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
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
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
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com

Device Dimensions

Length70 Millimeter
Length70 Millimeter
Length70 Millimeter
Length70 Millimeter
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Length70 Millimeter
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Outer Diameter4 Millimeter
Length70 Millimeter
Outer Diameter4 Millimeter
Length70 Millimeter
Outer Diameter4 Millimeter
Length70 Millimeter
Outer Diameter4 Millimeter
Length70 Millimeter
Outer Diameter4 Millimeter
Length70 Millimeter
Outer Diameter4 Millimeter
Length70 Millimeter
Outer Diameter4 Millimeter
Length70 Millimeter
Outer Diameter4 Millimeter
Length70 Millimeter
Outer Diameter4 Millimeter
Length70 Millimeter
Outer Diameter4 Millimeter
Length70 Millimeter
Outer Diameter4 Millimeter
Length70 Millimeter
Outer Diameter4 Millimeter
Length70 Millimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep Dry. Do Not Use if Package is Damaged
Handling Environment Atmospheric PressureBetween 500 millibar and 1050 millibar
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 500 millibar and 1050 millibar
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep Dry. Do Not Use if Package is Damaged
Handling Environment Atmospheric PressureBetween 500 millibar and 1050 millibar
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 500 millibar and 1050 millibar
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep Dry. Do Not Use if Package is Damaged
Handling Environment Atmospheric PressureBetween 500 millibar and 1050 millibar
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 500 millibar and 1050 millibar
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep Dry. Do Not Use if Package is Damaged
Handling Environment Atmospheric PressureBetween 500 millibar and 1050 millibar
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 500 millibar and 1050 millibar
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep Dry. Do Not Use if Package is Damaged
Handling Environment Atmospheric PressureBetween 500 millibar and 1050 millibar
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 500 millibar and 1050 millibar
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep Dry. Do Not Use if Package is Damaged
Handling Environment Atmospheric PressureBetween 500 millibar and 1050 millibar
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 500 millibar and 1050 millibar
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep Dry. Do Not Use if Package is Damaged
Handling Environment Atmospheric PressureBetween 500 millibar and 1050 millibar
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 500 millibar and 1050 millibar
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep Dry. Do Not Use if Package is Damaged
Handling Environment Atmospheric PressureBetween 500 millibar and 1050 millibar
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 500 millibar and 1050 millibar
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep Dry. Do Not Use if Package is Damaged
Handling Environment Atmospheric PressureBetween 500 millibar and 1050 millibar
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 500 millibar and 1050 millibar
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep Dry. Do Not Use if Package is Damaged
Handling Environment Atmospheric PressureBetween 500 millibar and 1050 millibar
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 500 millibar and 1050 millibar
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep Dry. Do Not Use if Package is Damaged
Handling Environment Atmospheric PressureBetween 500 millibar and 1050 millibar
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 500 millibar and 1050 millibar
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep Dry. Do Not Use if Package is Damaged
Handling Environment Atmospheric PressureBetween 500 millibar and 1050 millibar
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 500 millibar and 1050 millibar
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100850002332223 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEIElectrosurgical, Cutting & Coagulation & Accessories

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-01-20
Device Publish Date2021-01-12

On-Brand Devices [AURORA Evacuator +Coag]

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

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