AutoPlex VertaPlex 0707-002-000

GUDID 07613327545258

M4 Cement Mixer for Manifold with HV Bone Cement

STRYKER CORPORATION

Orthopaedic cement preparation/delivery kit

• Primary Device ID: 07613327545258
• NIH Device Record Key: fb791df4-2ffd-438d-ae6f-798be3c468e7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AutoPlex VertaPlex
• Version Model Number: 0707002000
• Catalog Number: 0707-002-000
• Company DUNS: 196548481
• Company Name: STRYKER CORPORATION
• 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: true
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)253-3210
• Email: inst.stryker.cs@stryker.com
• Phone: +1(800)253-3210
• Email: inst.stryker.cs@stryker.com
• Phone: +1(800)253-3210
• Email: inst.stryker.cs@stryker.com
• Phone: +1(800)253-3210
• Email: inst.stryker.cs@stryker.com
• Phone: +1(800)253-3210
• Email: inst.stryker.cs@stryker.com
• Phone: +1(800)253-3210
• Email: inst.stryker.cs@stryker.com
• Phone: +1(800)253-3210
• Email: inst.stryker.cs@stryker.com
• Phone: +1(800)253-3210
• Email: inst.stryker.cs@stryker.com
• Phone: +1(800)253-3210
• Email: inst.stryker.cs@stryker.com
• Phone: +1(800)253-3210
• Email: inst.stryker.cs@stryker.com

Operating and Storage Conditions

• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327545258 [Primary]

FDA Product Code

• JDZ: MIXER, CEMENT, FOR CLINICAL USE

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: 2024-11-29
• Device Publish Date: 2024-11-21

On-Brand Devices [AutoPlex VertaPlex]

• 07613327545265: M4 Cement Mixer with HV Bone Cement
• 07613327545258: M4 Cement Mixer for Manifold with HV Bone Cement