3D Bond

GUDID 07290014838062

AUGMA BIOMATERIALS LTD

Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft

• Primary Device ID: 07290014838062
• NIH Device Record Key: b446041d-f22a-4341-b14d-731ba15d8967
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3D Bond
• Version Model Number: DD-100
• Company DUNS: 533432352
• Company Name: AUGMA BIOMATERIALS LTD
• Device Count: 2
• DM Exempt: true
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290014838062 [Primary]
GS1	17290014838069 [Unit of Use]

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-03-11
• Device Publish Date: 2024-03-03

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