High Viscosity Injection System T060421

GUDID 03760177043107

TEKNIMED

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 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: 03760177043107
• NIH Device Record Key: 28e6adc7-4d73-4d32-95af-99dbe3d1178a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: High Viscosity Injection System
• Version Model Number: T060421
• Catalog Number: T060421
• Company DUNS: 764746723
• Company Name: TEKNIMED
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	03760177043107 [Primary]

FDA Product Code

• OAR: Injector, Vertebroplasty (Does Not Contain 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: 2021-12-24
• Device Publish Date: 2021-12-16

Devices Manufactured by TEKNIMED

• 03701505800016 - EUROSCREW NG Screwdriver Shaft: 2024-01-30
• 03701505800139 - Ratchet Handle: 2024-01-30
• 03701505800863 - TAP NG: 2024-01-29
• 03701505800870 - TAP NG: 2024-01-29
• 03701505800887 - TAP NG: 2024-01-29
• 03701505800894 - TAP NG: 2024-01-29
• 03701505800900 - TAP NG: 2024-01-29
• 03701505800917 - TAP NG: 2024-01-29