Bonalive Orthopedics granules 14140

GUDID 06438132141409

Synthetic bone substitute for regenerating bone

BonAlive Biomaterials Oy

Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial

• Primary Device ID: 06438132141409
• NIH Device Record Key: 281e67bd-2d23-4c07-bb90-73e5e3b00580
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bonalive Orthopedics granules
• Version Model Number: 14140
• Catalog Number: 14140
• Company DUNS: 367881400
• Company Name: BonAlive Biomaterials Oy
• 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: false
• Manufacturing Date: false
• 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

Customer Support Contacts

• Phone: +358401774400
• Email: contact@bonalive.com
• Phone: +358401774400
• Email: contact@bonalive.com
• Phone: +358401774400
• Email: contact@bonalive.com
• Phone: +358401774400
• Email: contact@bonalive.com
• Phone: +358401774400
• Email: contact@bonalive.com
• Phone: +358401774400
• Email: contact@bonalive.com
• Phone: +358401774400
• Email: contact@bonalive.com
• Phone: +358401774400
• Email: contact@bonalive.com
• Phone: +358401774400
• Email: contact@bonalive.com
• Phone: +358401774400
• Email: contact@bonalive.com
• Phone: +358401774400
• Email: contact@bonalive.com
• Phone: +358401774400
• Email: contact@bonalive.com
• Phone: +358401774400
• Email: contact@bonalive.com

Device Dimensions

• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	06438132141409 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191274

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-09-08
• Device Publish Date: 2020-08-31

On-Brand Devices [Bonalive Orthopedics granules]

• 06438132143403: Synthetic bone substitute for regenerating bone
• 06438132143304: Synthetic bone substitute for regenerating bone
• 06438132141409: Synthetic bone substitute for regenerating bone
• 06438132141300: Synthetic bone substitute for regenerating bone
• 06438132141201: Synthetic bone substitute for regenerating bone
• 06438132141102: Synthetic bone substitute for regenerating bone