Mixing System Adapted to High Viscosity Injection System T060420

GUDID 03760177043138

TEKNIMED

Orthopaedic cement preparation/delivery kit

• Primary Device ID: 03760177043138
• NIH Device Record Key: 804d2a09-4487-498e-8baf-4f39b7b75c3b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mixing System Adapted to High Viscosity Injection System
• Version Model Number: T060420
• Catalog Number: T060420
• 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	03760177043138 [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: 2021-12-24
• Device Publish Date: 2021-12-16

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• 03701505801037 - META+ System 1.5cc MV: 2025-04-08
• 03701505801075 - PUREKIT Syringes: 2025-04-08
• 03701505801082 - Syringes 4cc: 2025-04-08
• 03701505801099 - Syringes 1.5cc: 2025-04-08
• 03760177045361 - PureKit Gun MV: 2025-04-01
• 03760177040113 - OPACITY +: 2024-09-05
• 03760177041110 - F20: 2024-09-05