LEVÓ ARM, REFURBISHED 7887-050R

GUDID 00842430108440

MIZUHO ORTHOPEDIC SYSTEMS, INC.

Head/neck procedure positioner

• Primary Device ID: 00842430108440
• NIH Device Record Key: 13f52d4a-2107-4951-a46e-2c9d6471d180
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LEVÓ ARM, REFURBISHED
• Version Model Number: 7887-050R
• Catalog Number: 7887-050R
• 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: 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842430108440 [Primary]

FDA Product Code

• JEA: Table, Surgical With Orthopedic Accessories, Ac-Powered

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: 2018-11-12
• Device Publish Date: 2018-10-12

Devices Manufactured by MIZUHO ORTHOPEDIC SYSTEMS, INC.

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• 10842430111539 - PKIT, INDIV W/SHEARGARD, SST-3000 (1): 2024-05-20
• 00842430116322 - AQUARI IMMERSION CONTROLLER REFURB: 2024-03-15