iDrive Ultra

GUDID 10884521142794

Reusable Powered Handle

Covidien LP

Open-surgery manual linear stapler, reusable

• Primary Device ID: 10884521142794
• NIH Device Record Key: f43fa2de-ad37-4542-9e28-f47bd6f2aee1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iDrive Ultra
• Version Model Number: IDRVULTRA1
• Company DUNS: 058614483
• Company Name: Covidien LP
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com

Operating and Storage Conditions

• Handling Environment Atmospheric Pressure: Between 0.7 KiloPascal and 1.06 KiloPascal
• Storage Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 0.7 KiloPascal and 1.06 KiloPascal
• Storage Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 0.7 KiloPascal and 1.06 KiloPascal
• Storage Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 0.7 KiloPascal and 1.06 KiloPascal
• Storage Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 0.7 KiloPascal and 1.06 KiloPascal
• Storage Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 0.7 KiloPascal and 1.06 KiloPascal
• Storage Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 0.7 KiloPascal and 1.06 KiloPascal
• Storage Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 0.7 KiloPascal and 1.06 KiloPascal
• Storage Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 0.7 KiloPascal and 1.06 KiloPascal
• Storage Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 0.7 KiloPascal and 1.06 KiloPascal
• Storage Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 0.7 KiloPascal and 1.06 KiloPascal
• Storage Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 0.7 KiloPascal and 1.06 KiloPascal
• Storage Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 0.7 KiloPascal and 1.06 KiloPascal
• Storage Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 0.7 KiloPascal and 1.06 KiloPascal
• Storage Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 0.7 KiloPascal and 1.06 KiloPascal
• Storage Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 0.7 KiloPascal and 1.06 KiloPascal
• Storage Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 0.7 KiloPascal and 1.06 KiloPascal
• Storage Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 0.7 KiloPascal and 1.06 KiloPascal
• Storage Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 0.7 KiloPascal and 1.06 KiloPascal
• Storage Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 0.7 KiloPascal and 1.06 KiloPascal
• Storage Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 0.7 KiloPascal and 1.06 KiloPascal
• Storage Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 0.7 KiloPascal and 1.06 KiloPascal
• Storage Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 0.7 KiloPascal and 1.06 KiloPascal
• Storage Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 0.7 KiloPascal and 1.06 KiloPascal
• Storage Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 0.7 KiloPascal and 1.06 KiloPascal
• Storage Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 0.7 KiloPascal and 1.06 KiloPascal
• Storage Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 0.7 KiloPascal and 1.06 KiloPascal
• Storage Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 0.7 KiloPascal and 1.06 KiloPascal
• Storage Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 0.7 KiloPascal and 1.06 KiloPascal
• Storage Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 0.7 KiloPascal and 1.06 KiloPascal
• Storage Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 0.7 KiloPascal and 1.06 KiloPascal
• Storage Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 0.7 KiloPascal and 1.06 KiloPascal
• Storage Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521142794 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121510

FDA Product Code

• GDW: STAPLE, IMPLANTABLE

Sterilization

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

[10884521142794]

Moist Heat or Steam Sterilization

[10884521142794]

Moist Heat or Steam Sterilization

[10884521142794]

Moist Heat or Steam Sterilization

[10884521142794]

Moist Heat or Steam Sterilization

[10884521142794]

Moist Heat or Steam Sterilization

[10884521142794]

Moist Heat or Steam Sterilization

[10884521142794]

Moist Heat or Steam Sterilization

[10884521142794]

Moist Heat or Steam Sterilization

[10884521142794]

Moist Heat or Steam Sterilization

[10884521142794]

Moist Heat or Steam Sterilization

[10884521142794]

Moist Heat or Steam Sterilization

[10884521142794]

Moist Heat or Steam Sterilization

[10884521142794]

Moist Heat or Steam Sterilization

[10884521142794]

Moist Heat or Steam Sterilization

[10884521142794]

Moist Heat or Steam Sterilization

[10884521142794]

Moist Heat or Steam Sterilization

[10884521142794]

Moist Heat or Steam Sterilization

[10884521142794]

Moist Heat or Steam Sterilization

[10884521142794]

Moist Heat or Steam Sterilization

[10884521142794]

Moist Heat or Steam Sterilization

[10884521142794]

Moist Heat or Steam Sterilization

[10884521142794]

Moist Heat or Steam Sterilization

[10884521142794]

Moist Heat or Steam Sterilization

[10884521142794]

Moist Heat or Steam Sterilization

[10884521142794]

Moist Heat or Steam Sterilization

[10884521142794]

Moist Heat or Steam Sterilization

[10884521142794]

Moist Heat or Steam Sterilization

[10884521142794]

Moist Heat or Steam Sterilization

[10884521142794]

Moist Heat or Steam Sterilization

[10884521142794]

Moist Heat or Steam Sterilization

[10884521142794]

Moist Heat or Steam Sterilization

[10884521142794]

Moist Heat or Steam Sterilization

[10884521142794]

Moist Heat or Steam Sterilization

[10884521142794]

Moist Heat or Steam Sterilization

[10884521142794]

Moist Heat or Steam Sterilization

[10884521142794]

Moist Heat or Steam Sterilization

[10884521142794]

Moist Heat or Steam Sterilization

[10884521142794]

Moist Heat or Steam Sterilization

[10884521142794]

Moist Heat or Steam Sterilization

[10884521142794]

Moist Heat or Steam Sterilization

[10884521142794]

Moist Heat or Steam Sterilization

[10884521142794]

Moist Heat or Steam Sterilization

[10884521142794]

Moist Heat or Steam Sterilization

[10884521142794]

Moist Heat or Steam Sterilization

[10884521142794]

Moist Heat or Steam Sterilization

[10884521142794]

Moist Heat or Steam Sterilization

[10884521142794]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-04-05
• Device Publish Date: 2016-09-24

On-Brand Devices [iDrive Ultra]

• 10884521510579: Reusable Powered Handle
• 10884521144415: Reusable Sterilization Tray
• 10884521142794: Reusable Powered Handle
• 10884521144408: Reusable Manual Adapter Tool