Harvey Surgical Assistant (HSA) 405080

GUDID 00810832031130

Packaged Assembly, Navigation Unit, HSA

ORTHALIGN, INC.

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• Primary Device ID: 00810832031130
• NIH Device Record Key: a309009b-951f-4e9a-8ebb-4cfcbef5d385
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Harvey Surgical Assistant (HSA)
• Version Model Number: 405080
• Catalog Number: 405080
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810832031130 [Primary]
GS1	10810832031137 [Package]; Package: Shipper Box [3 Units]; In Commercial Distribution
GS1	20810832031134 [Package]; Package: Shipper Box [2 Units]; In Commercial Distribution
GS1	30810832031131 [Package]; Package: Shipper Box [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200892

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: 2020-09-24
• Device Publish Date: 2020-09-16

On-Brand Devices [Harvey Surgical Assistant (HSA)]

• 00810832031222: Harvey Surgical Assistant (HSA) Instrument Set
• 00810832031130: Packaged Assembly, Navigation Unit, HSA
• 00810832030980: Reference Sensor (RS), HSA
• 00810832030973: KA2 Bracket, Nav Unit, HSA
• 00810832030966: KA2 Bracket, RS, HSA