Bio V BP Bioactive Glass with DBM Putty BGP001-01

GUDID 00858686006041

Synthetic bone void filler containing DBM for orthopedic applications, provided in a syringe dispenser

AMEND SURGICAL, INC.

Cadaveric-donor/synthetic mineral bone graft Cadaveric-donor/synthetic mineral bone graft Cadaveric-donor/synthetic mineral bone graft Cadaveric-donor/synthetic mineral bone graft Cadaveric-donor/synthetic mineral bone graft Cadaveric-donor/synthetic mineral bone graft Cadaveric-donor/synthetic mineral bone graft Cadaveric-donor/synthetic mineral bone graft Cadaveric-donor/synthetic mineral bone graft Cadaveric-donor/synthetic mineral bone graft Cadaveric-donor/synthetic mineral bone graft Cadaveric-donor/synthetic mineral bone graft Cadaveric-donor/synthetic mineral bone graft Cadaveric-donor/synthetic mineral bone graft Cadaveric-donor/synthetic mineral bone graft Cadaveric-donor/synthetic mineral bone graft Cadaveric-donor/synthetic mineral bone graft

• Primary Device ID: 00858686006041
• NIH Device Record Key: b2bc7ad9-c6e4-408b-9e9a-26a3736a80f9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bio V BP Bioactive Glass with DBM Putty
• Version Model Number: BGP001-01
• Catalog Number: BGP001-01
• Company DUNS: 080131031
• Company Name: AMEND SURGICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: true
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8442813169
• Email: smathison@amendsurgical.com
• Phone: 8442813169
• Email: smathison@amendsurgical.com
• Phone: 8442813169
• Email: smathison@amendsurgical.com
• Phone: 8442813169
• Email: smathison@amendsurgical.com
• Phone: 8442813169
• Email: smathison@amendsurgical.com
• Phone: 8442813169
• Email: smathison@amendsurgical.com
• Phone: 8442813169
• Email: smathison@amendsurgical.com
• Phone: 8442813169
• Email: smathison@amendsurgical.com
• Phone: 8442813169
• Email: smathison@amendsurgical.com
• Phone: 8442813169
• Email: smathison@amendsurgical.com
• Phone: 8442813169
• Email: smathison@amendsurgical.com
• Phone: 8442813169
• Email: smathison@amendsurgical.com
• Phone: 8442813169
• Email: smathison@amendsurgical.com
• Phone: 8442813169
• Email: smathison@amendsurgical.com
• Phone: 8442813169
• Email: smathison@amendsurgical.com
• Phone: 8442813169
• Email: smathison@amendsurgical.com
• Phone: 8442813169
• Email: smathison@amendsurgical.com

Device Dimensions

• Total Volume: 1 Milliliter
• Total Volume: 1 Milliliter
• Total Volume: 1 Milliliter
• Total Volume: 1 Milliliter
• Total Volume: 1 Milliliter
• Total Volume: 1 Milliliter
• Total Volume: 1 Milliliter
• Total Volume: 1 Milliliter
• Total Volume: 1 Milliliter
• Total Volume: 1 Milliliter
• Total Volume: 1 Milliliter
• Total Volume: 1 Milliliter
• Total Volume: 1 Milliliter
• Total Volume: 1 Milliliter
• Total Volume: 1 Milliliter
• Total Volume: 1 Milliliter
• Total Volume: 1 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 37 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858686006041 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142104

FDA Product Code

• MBP: Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-01-12

On-Brand Devices [Bio V BP Bioactive Glass with DBM Putty]

• 00858686006072: Synthetic bone void filler containing DBM for orthopedic applications, provided in a syringe dis
• 00858686006041: Synthetic bone void filler containing DBM for orthopedic applications, provided in a syringe dis