ZENTRUM LEG SECTION, RIGHT, US 8000-23-U

GUDID 00842430108730

MIZUHO ORTHOPEDIC SYSTEMS, INC.

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• Primary Device ID: 00842430108730
• NIH Device Record Key: 6ae9f256-a97b-4132-8b4b-e22b459fd956
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ZENTRUM LEG SECTION, RIGHT, US
• Version Model Number: 8000-23-U
• Catalog Number: 8000-23-U
• 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: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• 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 Temperature: Between 23 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 23 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 23 Degrees Fahrenheit and 113 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 23 Degrees Fahrenheit and 113 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 23 Degrees Fahrenheit and 113 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 23 Degrees Fahrenheit and 113 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 23 Degrees Fahrenheit and 113 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 23 Degrees Fahrenheit and 113 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 23 Degrees Fahrenheit and 113 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 23 Degrees Fahrenheit and 113 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 23 Degrees Fahrenheit and 113 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 23 Degrees Fahrenheit and 113 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 23 Degrees Fahrenheit and 113 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 23 Degrees Fahrenheit and 113 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 23 Degrees Fahrenheit and 113 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 23 Degrees Fahrenheit and 113 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 23 Degrees Fahrenheit and 113 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 23 Degrees Fahrenheit and 113 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 23 Degrees Fahrenheit and 113 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 23 Degrees Fahrenheit and 113 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842430108730 [Primary]

FDA Product Code

• GDC: Table, Operating-Room, Electrical

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: 2018-12-28
• Device Publish Date: 2018-11-27

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