DWD011

GUDID 03700386929885

CEMENT KIT FOR KEELED GLENOID

TORNIER

Orthopaedic cement preparation/delivery kit Orthopaedic cement preparation/delivery kit Orthopaedic cement preparation/delivery kit Orthopaedic cement preparation/delivery kit Orthopaedic cement preparation/delivery kit Orthopaedic cement preparation/delivery kit Orthopaedic cement preparation/delivery kit Orthopaedic cement preparation/delivery kit Orthopaedic cement preparation/delivery kit Orthopaedic cement preparation/delivery kit Orthopaedic cement preparation/delivery kit Orthopaedic cement preparation/delivery kit

• Primary Device ID: 03700386929885
• NIH Device Record Key: 4193af00-7967-4c2d-ab55-cb102454163e
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: DWD011
• Catalog Number: DWD011
• Company DUNS: 260324876
• Company Name: TORNIER
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +330476613500
• Email: order@tornier.com
• Phone: +330476613500
• Email: order@tornier.com
• Phone: +330476613500
• Email: order@tornier.com
• Phone: +330476613500
• Email: order@tornier.com
• Phone: +330476613500
• Email: order@tornier.com
• Phone: +330476613500
• Email: order@tornier.com
• Phone: +330476613500
• Email: order@tornier.com
• Phone: +330476613500
• Email: order@tornier.com
• Phone: +330476613500
• Email: order@tornier.com
• Phone: +330476613500
• Email: order@tornier.com
• Phone: +330476613500
• Email: order@tornier.com
• Phone: +330476613500
• Email: order@tornier.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	03700386929885 [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: 2022-12-09
• Device Publish Date: 2022-12-01

Devices Manufactured by TORNIER

• 03700434023695 - Shoulder iD: 2024-05-31 BLUEPRINT Primary Reversed Glenoid Guide
• 03700434023701 - Shoulder iD: 2024-05-31 BLUEPRINT Primary Reversed Glenoid Guide
• 03700434023718 - Shoulder iD: 2024-05-31 BLUEPRINT Primary Reversed Glenoid Guide
• 03700434023725 - Shoulder iD: 2024-05-31 BLUEPRINT Primary Reversed Glenoid Guide
• 03700434023732 - Shoulder iD: 2024-05-31 BLUEPRINT Primary Reversed Bone Model
• 03700434023817 - Aequalis Reversed II: 2024-05-30 Hexagonal Tip AO
• 03700386999345 - Aequalis Reversed II: 2024-05-02 Silicone Pad
• 03700386999352 - Tornier Perform Anatomic Glenoid: 2024-05-02 Lid