PRISM™ II Vacuum Mixing Cartridge

GUDID 25060238200060

Vacuum Mixing Cartridge

SUMMIT MEDICAL LIMITED

Orthopaedic cement preparation/delivery kit

• Primary Device ID: 25060238200060
• NIH Device Record Key: fa8d25cb-21ce-4550-b583-44f69e963121
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PRISM™ II Vacuum Mixing Cartridge
• Version Model Number: 5401-33-500
• 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
• Phone: +441451821311
• Email: info@summit-medical.co.uk
• Phone: +441451821311
• Email: info@summit-medical.co.uk

Device Identifiers

Device Issuing Agency	Device ID
GS1	15060238200063 [Primary]
GS1	25060238200060 [Package]; Contains: 15060238200063; 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: 2022-12-01
• Device Publish Date: 2022-11-23

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• 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