3D Bond

GUDID 17290014838007

‎3D Bond is a synthetic, osteoconductive, ‎bioresorbable graft binder cement composed ‎of biphasic Calcium Sulfate in a granulated ‎powder form. 3D B

AUGMA BIOMATERIALS LTD

Synthetic bone graft

• Primary Device ID: 17290014838007
• NIH Device Record Key: a9adeb38-f97b-49a3-95b7-a3a160b34a21
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3D Bond
• Version Model Number: DD2-050
• Company DUNS: 533432352
• Company Name: AUGMA BIOMATERIALS LTD
• 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: 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 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290014838000 [Primary]
GS1	17290014838007 [Package]; Contains: 07290014838000; Package: [2 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083858

FDA Product Code

• LYC: Bone Grafting Material, Synthetic

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: 2015-09-10

On-Brand Devices [3D Bond ]

• 17290014838014: ‎3D Bond is a synthetic, osteoconductive, ‎bioresorbable graft binder cement composed ‎of
• 17290014838007: ‎3D Bond is a synthetic, osteoconductive, ‎bioresorbable graft binder cement composed ‎of
• 07290014838062: DD-100