BONEFUSE US822510

GUDID 03760177041837

TEKNIMED

Bone matrix implant, synthetic, non-antimicrobial

• Primary Device ID: 03760177041837
• NIH Device Record Key: a06ffdea-6e14-4c8b-b4c4-b9cf8fbb2003
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BONEFUSE
• Version Model Number: Chips 2-5mm 10cc
• Catalog Number: US822510
• 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

Device Dimensions

• Device Size Text, specify: 0
• Pore Size: 220 Micrometer
• Weight: 3.85 Gram
• Device Size Text, specify: 0
• Pore Size: 220 Micrometer
• Weight: 3.85 Gram
• Device Size Text, specify: 0
• Pore Size: 220 Micrometer
• Weight: 3.85 Gram
• Device Size Text, specify: 0
• Pore Size: 220 Micrometer
• Weight: 3.85 Gram
• Device Size Text, specify: 0
• Pore Size: 220 Micrometer
• Weight: 3.85 Gram
• Device Size Text, specify: 0
• Pore Size: 220 Micrometer
• Weight: 3.85 Gram
• Device Size Text, specify: 0
• Pore Size: 220 Micrometer
• Weight: 3.85 Gram
• Device Size Text, specify: 0
• Pore Size: 220 Micrometer
• Weight: 3.85 Gram
• Device Size Text, specify: 0
• Pore Size: 220 Micrometer
• Weight: 3.85 Gram

Device Identifiers

Device Issuing Agency	Device ID
GS1	03760177041837 [Primary]

FDA Product Code

• MQV: Filler, Bone Void, Calcium Compound

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-10-26
• Device Publish Date: 2015-10-16

On-Brand Devices [BONEFUSE]

• 03760177041912: Stick 5x5x20 10 units
• 03760177041905: Stick 5x5x20 5 units
• 03760177041899: Granules 3x3x3 30cc
• 03760177041868: Granules 3x3x3 10cc
• 03760177041851: Granules 3x3x3 5cc
• 03760177041844: Chips 2-5mm 20cc
• 03760177041837: Chips 2-5mm 10cc
• 03760177041820: Chips 1-2mm 20cc
• 03760177041813: Chips 1-2mm 10cc