OptiTwist®

GUDID 25060238201265

Vacuum Mixing Bowl

SUMMIT MEDICAL LIMITED

Orthopaedic cement preparation/delivery kit

• Primary Device ID: 25060238201265
• NIH Device Record Key: 12be310a-e8d0-47b3-99af-5901fbe9e72f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OptiTwist®
• Version Model Number: 600-40-020
• 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
• Phone: +441451821311
• Email: info@summit-medical.co.uk
• Phone: +441451821311
• Email: info@summit-medical.co.uk

Device Identifiers

Device Issuing Agency	Device ID
GS1	15060238201268 [Primary]
GS1	25060238201265 [Package]; Contains: 15060238201268; Package: Carton [20 Units]; In Commercial Distribution

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: 2022-12-12
• Device Publish Date: 2022-12-02

Devices Manufactured by SUMMIT MEDICAL LIMITED

• 25060238201593 - Femoral Cement Pressuriser: 2025-01-20 Femoral Cement Pressuriser
• 25060238201630 - HiVac™ 7 Triple Mix: 2025-01-20 HiVac™ 7 Triple Mix
• 25060238201654 - HiVac™ 7 with Femoral Cement Pressuriser: 2025-01-20 HiVac™ 7 with Femoral Cement Pressuriser
• 25060238201678 - HiVac™ Syringe: 2025-01-20 HiVac™ Syringe
• 25060238201685 - HiVac™ Syringe: 2025-01-20 HiVac™ Syringe
• 25060238201715 - 9mm Nozzle With Nozzle Extruder: 2025-01-20 9mm Nozzle With Nozzle Extruder
• 25060238201722 - Quick-Vac® Vacuum Mixing Bowl: 2025-01-20 Quick-Vac® Vacuum Mixing Bowl
• 25060238201739 - Quick-Vac® Vacuum Mixing Bowl: 2025-01-20 Quick-Vac® Vacuum Mixing Bowl