Perseus 20100801

GUDID 08052675960013

Perseus Device Sensor

ORTHOKEY ITALIA SRL

Orthopaedic stereotactic surgery system

• Primary Device ID: 08052675960013
• NIH Device Record Key: e411f66f-31b2-44ea-b610-0fed7ce690f2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Perseus
• Version Model Number: 20100801
• Catalog Number: 20100801
• Company DUNS: 433594191
• Company Name: ORTHOKEY ITALIA SRL
• Device Count: 1
• DM Exempt: true
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +39055354829
• Email: customer.service@orthokey.eu
• Phone: +39055354829
• Email: customer.service@orthokey.eu
• Phone: +39055354829
• Email: customer.service@orthokey.eu
• Phone: +39055354829
• Email: customer.service@orthokey.eu
• Phone: +39055354829
• Email: customer.service@orthokey.eu
• Phone: +39055354829
• Email: customer.service@orthokey.eu
• Phone: +39055354829
• Email: customer.service@orthokey.eu
• Phone: +39055354829
• Email: customer.service@orthokey.eu
• Phone: +39055354829
• Email: customer.service@orthokey.eu
• Phone: +39055354829
• Email: customer.service@orthokey.eu
• Phone: +39055354829
• Email: customer.service@orthokey.eu
• Phone: +39055354829
• Email: customer.service@orthokey.eu
• Phone: +39055354829
• Email: customer.service@orthokey.eu
• Phone: +39055354829
• Email: customer.service@orthokey.eu
• Phone: +39055354829
• Email: customer.service@orthokey.eu
• Phone: +39055354829
• Email: customer.service@orthokey.eu

Operating and Storage Conditions

• Storage Environment Temperature: Between -25 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Handle with care. Products should be stored in a clean, cool, dry area, away fromchemical fume
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Handle with care. Products should be stored in a clean, cool, dry area, away fromchemical fume
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Handle with care. Products should be stored in a clean, cool, dry area, away fromchemical fume
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Handle with care. Products should be stored in a clean, cool, dry area, away fromchemical fume
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Handle with care. Products should be stored in a clean, cool, dry area, away fromchemical fume
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Handle with care. Products should be stored in a clean, cool, dry area, away fromchemical fume
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Handle with care. Products should be stored in a clean, cool, dry area, away fromchemical fume
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Handle with care. Products should be stored in a clean, cool, dry area, away fromchemical fume
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Handle with care. Products should be stored in a clean, cool, dry area, away fromchemical fume
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Handle with care. Products should be stored in a clean, cool, dry area, away fromchemical fume
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Handle with care. Products should be stored in a clean, cool, dry area, away fromchemical fume
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Handle with care. Products should be stored in a clean, cool, dry area, away fromchemical fume
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Handle with care. Products should be stored in a clean, cool, dry area, away fromchemical fume
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Handle with care. Products should be stored in a clean, cool, dry area, away fromchemical fume
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Handle with care. Products should be stored in a clean, cool, dry area, away fromchemical fume
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Handle with care. Products should be stored in a clean, cool, dry area, away fromchemical fume
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08052675960013 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192653

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: 2021-12-17
• Device Publish Date: 2021-12-09

On-Brand Devices [Perseus]

• 08052675960013: Perseus Device Sensor
• 08052675960051: Perseus Tibial Cutting Guide R - 1.3 mm
• 08052675960037: Femur Cutting Guide 1.3 mm
• 08052675960020: Extramedullary Jig
• 08052675960204: Threaded Pin Ø 3.2 x 4.2 mm
• 08052675960198: Pin With Stop Ø 3.2 Lungh.40
• 08052675960181: Pin Ø 3.2 x 120 mm
• 08052675960174: Pin Ø 3.2 x 80 mm
• 08052675960112: Box Sterilizzation
• 08052675960105: Non Invasive Sensor Support (includes Silicon Strip, code 1165)
• 08052675960099: Jacobs Adaptor
• 08052675960082: Pin Extractor
• 08052675960068: Femoral Spacer 9 mm
• 08052675960044: Perseus Tibial Cutting Guide L - 1.3 mm
• 08052675960167: Femural Spacer 10 mm
• 08052675960143: Alignment Verification ROD