OrthAlign Plus 403001-07-CE

GUDID 00810832031796

OrthAlign Plus Unit - P3 (EU)

ORTHALIGN, INC.

Orthopaedic stereotactic surgery system

• Primary Device ID: 00810832031796
• NIH Device Record Key: 94b9ece1-4553-4fe0-ac72-9cdbd798af7d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OrthAlign Plus
• Version Model Number: 403001-07-CE
• Catalog Number: 403001-07-CE
• Company DUNS: 023266163
• Company Name: ORTHALIGN, INC.
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 866-582-0879
• Email: CustomerService@orthalign.com
• Phone: 866-582-0879
• Email: CustomerService@orthalign.com
• Phone: 866-582-0879
• Email: CustomerService@orthalign.com
• Phone: 866-582-0879
• Email: CustomerService@orthalign.com
• Phone: 866-582-0879
• Email: CustomerService@orthalign.com
• Phone: 866-582-0879
• Email: CustomerService@orthalign.com
• Phone: 866-582-0879
• Email: CustomerService@orthalign.com
• Phone: 866-582-0879
• Email: CustomerService@orthalign.com
• Phone: 866-582-0879
• Email: CustomerService@orthalign.com
• Phone: 866-582-0879
• Email: CustomerService@orthalign.com
• Phone: 866-582-0879
• Email: CustomerService@orthalign.com
• Phone: 866-582-0879
• Email: CustomerService@orthalign.com
• Phone: 866-582-0879
• Email: CustomerService@orthalign.com
• Phone: 866-582-0879
• Email: CustomerService@orthalign.com
• Phone: 866-582-0879
• Email: CustomerService@orthalign.com
• Phone: 866-582-0879
• Email: CustomerService@orthalign.com
• Phone: 866-582-0879
• Email: CustomerService@orthalign.com
• Phone: 866-582-0879
• Email: CustomerService@orthalign.com
• Phone: 866-582-0879
• Email: CustomerService@orthalign.com
• Phone: 866-582-0879
• Email: CustomerService@orthalign.com
• Phone: 866-582-0879
• Email: CustomerService@orthalign.com
• Phone: 866-582-0879
• Email: CustomerService@orthalign.com
• Phone: 866-582-0879
• Email: CustomerService@orthalign.com
• Phone: 866-582-0879
• Email: CustomerService@orthalign.com
• Phone: 866-582-0879
• Email: CustomerService@orthalign.com
• Phone: 866-582-0879
• Email: CustomerService@orthalign.com
• Phone: 866-582-0879
• Email: CustomerService@orthalign.com
• Phone: 866-582-0879
• Email: CustomerService@orthalign.com
• Phone: 866-582-0879
• Email: CustomerService@orthalign.com
• Phone: 866-582-0879
• Email: CustomerService@orthalign.com
• Phone: 866-582-0879
• Email: CustomerService@orthalign.com
• Phone: 866-582-0879
• Email: CustomerService@orthalign.com
• Phone: 866-582-0879
• Email: CustomerService@orthalign.com
• Phone: 866-582-0879
• Email: CustomerService@orthalign.com

Operating and Storage Conditions

• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 60 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handle with care. Products should be stored in a clean, cool, dry area, away from chemical fumes.
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 60 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handle with care. Products should be stored in a clean, cool, dry area, away from chemical fumes.
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 60 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handle with care. Products should be stored in a clean, cool, dry area, away from chemical fumes.
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 60 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handle with care. Products should be stored in a clean, cool, dry area, away from chemical fumes.
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 60 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handle with care. Products should be stored in a clean, cool, dry area, away from chemical fumes.
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 60 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handle with care. Products should be stored in a clean, cool, dry area, away from chemical fumes.
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 60 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handle with care. Products should be stored in a clean, cool, dry area, away from chemical fumes.
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 60 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handle with care. Products should be stored in a clean, cool, dry area, away from chemical fumes.
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 60 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handle with care. Products should be stored in a clean, cool, dry area, away from chemical fumes.
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 60 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handle with care. Products should be stored in a clean, cool, dry area, away from chemical fumes.
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 60 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handle with care. Products should be stored in a clean, cool, dry area, away from chemical fumes.
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 60 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handle with care. Products should be stored in a clean, cool, dry area, away from chemical fumes.
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 60 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handle with care. Products should be stored in a clean, cool, dry area, away from chemical fumes.
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 60 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handle with care. Products should be stored in a clean, cool, dry area, away from chemical fumes.
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 60 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handle with care. Products should be stored in a clean, cool, dry area, away from chemical fumes.
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 60 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handle with care. Products should be stored in a clean, cool, dry area, away from chemical fumes.
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 60 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handle with care. Products should be stored in a clean, cool, dry area, away from chemical fumes.
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 60 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handle with care. Products should be stored in a clean, cool, dry area, away from chemical fumes.
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 60 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handle with care. Products should be stored in a clean, cool, dry area, away from chemical fumes.
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 60 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handle with care. Products should be stored in a clean, cool, dry area, away from chemical fumes.
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 60 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handle with care. Products should be stored in a clean, cool, dry area, away from chemical fumes.
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 60 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handle with care. Products should be stored in a clean, cool, dry area, away from chemical fumes.
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 60 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handle with care. Products should be stored in a clean, cool, dry area, away from chemical fumes.
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 60 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handle with care. Products should be stored in a clean, cool, dry area, away from chemical fumes.
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 60 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handle with care. Products should be stored in a clean, cool, dry area, away from chemical fumes.
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 60 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handle with care. Products should be stored in a clean, cool, dry area, away from chemical fumes.
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 60 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handle with care. Products should be stored in a clean, cool, dry area, away from chemical fumes.
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 60 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handle with care. Products should be stored in a clean, cool, dry area, away from chemical fumes.
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 60 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handle with care. Products should be stored in a clean, cool, dry area, away from chemical fumes.
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 60 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handle with care. Products should be stored in a clean, cool, dry area, away from chemical fumes.
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 60 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handle with care. Products should be stored in a clean, cool, dry area, away from chemical fumes.
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 60 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handle with care. Products should be stored in a clean, cool, dry area, away from chemical fumes.
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 60 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handle with care. Products should be stored in a clean, cool, dry area, away from chemical fumes.
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 60 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handle with care. Products should be stored in a clean, cool, dry area, away from chemical fumes.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810832031796 [Primary]

FDA Product Code

• OLO: Orthopedic Stereotaxic Instrument

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: 2023-06-13
• Device Publish Date: 2023-06-05

On-Brand Devices [OrthAlign Plus]

• 00810832030423: HipAlign Inst Set: Universal Hip Set
• 00810832030416: HipAlign Inst Set: DA HipAlign Set w/ 90mm pins
• 00810832030409: HipAlign Inst Set: DA HipAlign Set
• 00810832030379: Fixation Pin, 4.0mm DIA x 90mm, 3.2mm Proximal End, 2-Pack, N/S
• 00810832030362: Universal Adapter, Clip, 17.6mm
• 00810832030355: Impactor, Straight, 4 Position, S/B
• 00810832030348: Impactor, Straight, 4 Position, S&N
• 00810832030331: Impactor, Straight, 4 Position, 1/4-28 DJO
• 00810832030324: Impactor, Straight, 4 Position, 7/16-20, DPY
• 00810832030317: Universal RS Adapter, Large- .485"-.750"
• 00810832030300: Universal RS Adapter, Small- .325"-.500"
• 00810832030294: Adapter,Implant,Off Impactr, M8x1.25, LIM
• 00810832030287: Implant Adapter, Magnetic, 9/16-7/8
• 00810832030270: Implant Adapter, Magnetic, 3/8-1/2
• 00810832030249: HIPALIGN INST. SET: DAA LL – Core Set
• 00810832030188: Impactor, Straight, Unibody, M10 x 1.5, MAX
• 00810832030171: Impactor, Straight, Unibody, 1/4-28, DJO
• 00810832030164: Impactor, Straight, Unibody, 3/8-32, WT
• 00810832030157: Impactor, Straight, Unibody, 5/16-24, ZIM
• 00810832030140: Impactor, Straight, Unibody, 3/8-16, S&N
• 00810832030133: Impactor, Straight, Unibody, 3/8-24, S/B
• 00810832030126: Impactor, Straight, Unibody, 7/16-20, DPY
• 00810832030102: Adapter,Implant,Str Impactr,M8x1.25,LIM
• 00810832030096: Impactor System Adapter, Lima
• 00810832030089: OrthAlign Plus Unit - Gap Balancing
• 00810832030065: Threaded Fixation Pin, 4.0 mm x 90mm, 3.2mm Proximal End
• 00810832030041: HIPALIGN INST. SET: DA/Supine Cup Placement
• 00810832030034: HIPALIGN INST. SET: DAA LL- Offset Impactor -03 Tray
• 00810832030027: HIPALIGN INST. SET: DAA LL- Straight Impactor -03 Tray
• 00810832030010: HIPALIGN INST. SET: DAA LL – US ONLY
• 00810832030003: KTIS Calibration Bracket
• 00858704006992: Adapter,Implant,Off Impactr,M10X1.5,MAXX
• 00858704006985: Adapter,Implant,Off Impactr,1/4-28,DJO
• 00858704006978: Adapter,Implant,Off Impactr,3/8-32,WT
• 00858704006961: Adapter,Implant,Off Impactr,3/8-16,S&N
• 00858704006954: Pin Driver, Tri-flat, Hudson Connector
• 00858704006947: Probe Mount, 60mm
• 00858704006930: Registration Probe
• 00858704006923: 5mm Trocar
• 00858704006916: Drill Guide, 140mm Cannula
• 00858704006909: Threaded Fixation Pin, 5MM X 170MM
• 00858704006893: Adapter,Implant,Str Impactr,1/4-28,DJO
• 00858704006886: Adapter,Implant,Str Impactr,M10x1.5,MAX
• 00858704006879: Adapter,Implant,Str Impactr,3/8-32,WT
• 00858704006862: Adapter,Implant,Str Impactr,3/8-16,S&N
• 00858704006855: Adapter,Implant,Str Impactr,7/16-20,DPY
• 00858704006848: Pin, Headless, Smooth, 65 mm
• 00858704006831: UniAlign, Midline Probe, Right
• 00858704006824: UniAlign Midline Probe, Left
• 00858704006817: UniAlign Tibial Jig Body