OPACITY + T040320Z

GUDID 03760177040113

TEKNIMED

Vertebral bone filler, non-bioabsorbable

• Primary Device ID: 03760177040113
• NIH Device Record Key: f15c7032-1e26-4f89-95a4-b4f8dc62db85
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OPACITY +
• Version Model Number: T040320Z
• Catalog Number: T040320Z
• Company DUNS: 764746723
• Company Name: TEKNIMED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	03760177040113 [Primary]

FDA Product Code

• NDN: Cement, Bone, Vertebroplasty

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2024-09-05
• Device Publish Date: 2015-10-16

Devices Manufactured by TEKNIMED

• 03701505801204 - Dynamo: 2026-02-10
• 03701505801211 - Dynamo: 2026-02-10
• 03701505801228 - Dynamo: 2026-02-10
• 03701505801235 - Dynamo: 2026-02-10
• 03760177044326 - Signature -x Cement: 2026-02-02
• 03760177044333 - Signature -x Cement: 2026-02-02
• 03760177044340 - Signature -x Cement: 2026-02-02
• 03760177040090 - GENTAFIX: 2025-09-10