OSTEOFLEX VCF-1009

GUDID 03760177046351

TEKNIMED

Vertebral bone filler, non-bioabsorbable Vertebral bone filler, non-bioabsorbable Vertebral bone filler, non-bioabsorbable Vertebral bone filler, non-bioabsorbable Vertebral bone filler, non-bioabsorbable Vertebral bone filler, non-bioabsorbable Vertebral bone filler, non-bioabsorbable Vertebral bone filler, non-bioabsorbable Vertebral bone filler, non-bioabsorbable Vertebral bone filler, non-bioabsorbable Vertebral bone filler, non-bioabsorbable Vertebral bone filler, non-bioabsorbable

• Primary Device ID: 03760177046351
• NIH Device Record Key: ea5da043-1677-4988-a373-2603844069fe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OSTEOFLEX
• Version Model Number: VCF-1009
• Catalog Number: VCF-1009
• Company DUNS: 764746723
• Company Name: TEKNIMED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	03760177046351 [Primary]

FDA Product Code

• NDN: Cement, Bone, Vertebroplasty

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: 2020-10-29
• Device Publish Date: 2020-10-21

On-Brand Devices [OSTEOFLEX]

• 03760177046320: VCF-1009
• 03760177042933: INTV-CEM
• 03760177046351: VCF-1009