CUSA® Clarity C7404SEA

GUDID 10381780533863

23kHz Standard Length Laparoscopic Tip

INTEGRA LIFESCIENCES (IRELAND) LIMITED

Soft-tissue ultrasonic surgical system handpiece tip, single-use

• Primary Device ID: 10381780533863
• NIH Device Record Key: a31e4faf-996c-4a04-b4cf-f3031e150ffc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CUSA® Clarity
• Version Model Number: C7404SEA
• Catalog Number: C7404SEA
• Company DUNS: 989925396
• Company Name: INTEGRA LIFESCIENCES (IRELAND) LIMITED
• 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: true
• 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

Operating and Storage Conditions

• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry; Do not use if package is damaged
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry; Do not use if package is damaged
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry; Do not use if package is damaged
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry; Do not use if package is damaged
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry; Do not use if package is damaged
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry; Do not use if package is damaged
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry; Do not use if package is damaged
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry; Do not use if package is damaged
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry; Do not use if package is damaged
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry; Do not use if package is damaged
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry; Do not use if package is damaged
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry; Do not use if package is damaged
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry; Do not use if package is damaged
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry; Do not use if package is damaged
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry; Do not use if package is damaged
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry; Do not use if package is damaged
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780533863 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221763

FDA Product Code

• LBK: Device, neurosurgical fragmentation and aspiration

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: 2022-09-14
• Device Publish Date: 2022-09-06

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