PURE KIT

GUDID 03760177045217

TEKNIMED

Orthopaedic cement preparation/delivery kit

• Primary Device ID: 03760177045217
• NIH Device Record Key: d386bd15-ee01-4290-8a15-8cfbc44c6c90
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PURE KIT
• Version Model Number: T060425
• 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	03760177045217 [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: 2022-05-11
• Device Publish Date: 2022-05-03

Devices Manufactured by TEKNIMED

• 03760177040090 - GENTAFIX: 2025-09-10
• 03760177040137 - GENTAFIX: 2025-09-10
• 03760177043176 - GENTAFIX: 2025-09-10
• 03701505801020 - PureKit Syringe 1.5cc MV: 2025-04-08
• 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