NanoFUSE Bioactive Strip ASI209-10

GUDID 00858686006089

Bone void filler comprised of 45S5 bioactive glass and a gelatin carrier, intended for implantation

AMEND SURGICAL, INC.

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

• Primary Device ID: 00858686006089
• NIH Device Record Key: 2988d07f-a4a4-4544-9571-92da5b3d6b99
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NanoFUSE Bioactive Strip
• Version Model Number: 50x25x7mm
• Catalog Number: ASI209-10
• 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: 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: 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

• Length: 50 Millimeter
• Length: 50 Millimeter
• Length: 50 Millimeter
• Length: 50 Millimeter
• Length: 50 Millimeter
• Length: 50 Millimeter
• Length: 50 Millimeter
• Length: 50 Millimeter
• Length: 50 Millimeter
• Length: 50 Millimeter
• Length: 50 Millimeter
• Length: 50 Millimeter
• Length: 50 Millimeter
• Length: 50 Millimeter
• Length: 50 Millimeter
• Length: 50 Millimeter
• Length: 50 Millimeter

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	00858686006089 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161996

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: 2019-07-24
• Device Publish Date: 2019-07-16

On-Brand Devices [NanoFUSE Bioactive Strip]

• 00858686006096: Bone void filler comprised of 45S5 bioactive glass and a gelatin carrier, intended for implantat
• 00858686006089: Bone void filler comprised of 45S5 bioactive glass and a gelatin carrier, intended for implantat