3D Bond+

GUDID 07290014838055

AUGMA BIOMATERIALS LTD

Synthetic bone graft

• Primary Device ID: 07290014838055
• NIH Device Record Key: 431145c6-c4ce-4e39-a8bb-4cd5c90af578
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3D Bond+
• Version Model Number: 3D-ND-050-NoEU
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290014838055 [Primary]

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: 2022-06-21
• Device Publish Date: 2022-06-10

On-Brand Devices [3D Bond+]

• 07290014838055: 3D-ND-050-NoEU
• 07290014838192: 3D-ND-LAA-NoEU
• 07290014838185: 3D-ND-LAM-NoEU
• 07290014838178: 3D-ND-LMM-NoEU