SmartMix™ Vacuum Syringe Plus 5401-76-511

GUDID 25060238201364

Bone cement mixing and delivery system

SUMMIT MEDICAL LIMITED

Orthopaedic cement preparation/delivery kit

• Primary Device ID: 25060238201364
• NIH Device Record Key: 0c1fc748-4a7b-4954-b58c-ee649a423df1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SmartMix™ Vacuum Syringe Plus
• Version Model Number: 5401-76-511
• Catalog Number: 5401-76-511
• Company DUNS: 221751311
• Company Name: SUMMIT MEDICAL LIMITED
• 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: 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: +441451821311
• Email: info@summit-medical.co.uk
• Phone: +441451821311
• Email: info@summit-medical.co.uk
• Phone: +441451821311
• Email: info@summit-medical.co.uk
• Phone: +441451821311
• Email: info@summit-medical.co.uk
• Phone: +441451821311
• Email: info@summit-medical.co.uk
• Phone: +441451821311
• Email: info@summit-medical.co.uk
• Phone: +441451821311
• Email: info@summit-medical.co.uk
• Phone: +441451821311
• Email: info@summit-medical.co.uk
• Phone: +441451821311
• Email: info@summit-medical.co.uk
• Phone: +441451821311
• Email: info@summit-medical.co.uk
• Phone: +441451821311
• Email: info@summit-medical.co.uk

Operating and Storage Conditions

• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	15060238201367 [Primary]
GS1	25060238201364 [Package]; Contains: 15060238201367; Package: Carton [10 Units]; In Commercial Distribution

FDA Product Code

• KIH: Dispenser, Cement

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: 2024-05-06
• Device Publish Date: 2024-04-26

Devices Manufactured by SUMMIT MEDICAL LIMITED

• 25060238201609 - 6mm Slim Flexible Nozzle: 2024-05-30 6mm Slim Flexible Nozzle
• 25060238201616 - HiVac™ 7: 2024-05-28 Mixing and Delivery System
• 25060238201357 - SmartMix™ Vacuum Syringe: 2024-05-06 Bone cement mixing and delivery system
• 25060238201364 - SmartMix™ Vacuum Syringe Plus: 2024-05-06Bone cement mixing and delivery system
• 25060238201364 - SmartMix™ Vacuum Syringe Plus: 2024-05-06 Bone cement mixing and delivery system
• 25060238201371 - SmartMix™ Delivery Gun: 2024-05-06 Bone Cement Delivery Gun
• 25060238201418 - SmartMix™ Syringe Kit: 2024-05-06 Bone cement delivery system
• 25060238201586 - SmartMix™ 9mm Narrow Nozzle: 2024-05-06 9mm Narrow Straight Nozzle
• 15060238200148 - SmartMix Vacuum Footpump and Airhose: 2023-02-17 SmartMix Vacuum Footpump and Airhose