AVRA BACK 3IN SKYTRON 3501,3600,3602 69483AVB

GUDID 00842430110351

MIZUHO ORTHOPEDIC SYSTEMS, INC.

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• Primary Device ID: 00842430110351
• NIH Device Record Key: 1078b950-b403-45dd-a8e0-2f96bba702b5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AVRA BACK 3IN SKYTRON 3501,3600,3602
• Version Model Number: 69483AVB
• Catalog Number: 69483AVB
• Company DUNS: 084527241
• Company Name: MIZUHO ORTHOPEDIC SYSTEMS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-888-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-888-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-888-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-888-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-888-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-888-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-888-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-888-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-888-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-888-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-888-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-888-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-888-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-888-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-888-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com

Operating and Storage Conditions

• Storage Environment Atmospheric Pressure: Between 75 KiloPascal and 105 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 75 KiloPascal and 105 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 75 KiloPascal and 105 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 75 KiloPascal and 105 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 75 KiloPascal and 105 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 75 KiloPascal and 105 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 75 KiloPascal and 105 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 75 KiloPascal and 105 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 75 KiloPascal and 105 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 75 KiloPascal and 105 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 75 KiloPascal and 105 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 75 KiloPascal and 105 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 75 KiloPascal and 105 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 75 KiloPascal and 105 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 75 KiloPascal and 105 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 75 KiloPascal and 105 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 75 KiloPascal and 105 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 75 KiloPascal and 105 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 75 KiloPascal and 105 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 75 KiloPascal and 105 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 75 KiloPascal and 105 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 75 KiloPascal and 105 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 75 KiloPascal and 105 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 75 KiloPascal and 105 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 75 KiloPascal and 105 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 75 KiloPascal and 105 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 75 KiloPascal and 105 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 75 KiloPascal and 105 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 75 KiloPascal and 105 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 75 KiloPascal and 105 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 75 KiloPascal and 105 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 75 KiloPascal and 105 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 75 KiloPascal and 105 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 75 KiloPascal and 105 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 75 KiloPascal and 105 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 75 KiloPascal and 105 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 75 KiloPascal and 105 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 75 KiloPascal and 105 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 75 KiloPascal and 105 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 75 KiloPascal and 105 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 75 KiloPascal and 105 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 75 KiloPascal and 105 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 75 KiloPascal and 105 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 75 KiloPascal and 105 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 75 KiloPascal and 105 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 75 KiloPascal and 105 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 75 KiloPascal and 105 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 75 KiloPascal and 105 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842430110351 [Primary]

FDA Product Code

• JFC: System, Pressure Measurement, Intermittent

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: 2021-06-28
• Device Publish Date: 2021-06-18

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• 00842430101328 - SPAR, LEG, LEFT, RADIOLUCENT, REFURBISHED: 2023-09-27
• 00842430101335 - SPAR ASSEMBLY, RIGHT, REFURBISHED: 2023-09-27
• 00842430101342 - SPAR ASSEMBLY, LEFT, REFURBISHED: 2023-09-27
• 00842430103414 - UPPER ARM SUPPORT & PAD, REFURBISHED: 2023-09-27