TRIOSITE 00-1109-005-25

GUDID H132001109005251

Synthetic Bone Resorbable Graft Disc

BIOMATLANTE

Bone matrix implant, synthetic

• Primary Device ID: H132001109005251
• NIH Device Record Key: 2177ea70-1162-4a07-b282-3c2767306030
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRIOSITE
• Version Model Number: 00-1109-005-25
• Catalog Number: 00-1109-005-25
• Company DUNS: 493710719
• Company Name: BIOMATLANTE
• Device Count: 1
• 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: true
• OTC Over-The-Counter: false

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	H132001109005251 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051774

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-05-11

On-Brand Devices [TRIOSITE]

• H132001109132151: Synthetic Bone Resorbable Graft Cone 12
• H132001109115021: Synthétic Bone Resorbable Graft Granules 2-4mm 16cc
• H132001109115011: Synthetic bone Resorbable Graft Granules 2-3mm
• H132001109114021: Synthetic Bone Resorbable Graft Stick 5x5x20mm
• H132001109113011: Synthetic Bone Resorbable Graft Stick 5x5x10mm
• H132001109085151: Synthetic Bone Resorbable Graft Cone
• H132001109006121: Synthetic Bone Resorbable Graft Wedge 12mm
• H132001109005251: Synthetic Bone Resorbable Graft Disc
• H132001109005101: Synthetic Bone Resorbable Graft Wedge 10mm
• H132001109005031: Synthetic Bone Resorbable Graft Granules 2-3mm 5cc
• H132001109000481: Synthetic Bone Resorbable Graft Wedge 8mm
• H132001109000361: Synthetic Bone Resorbable Graft Wedge 6mm
• H132000060130001: Synthetic Bone Resorbable Graft Granules 0.5-1mm
• H131001109114011: Synthetic Bone Resorbable Graft Stick 5x5x20mm
• H131001109113021: synthetic Bone Resorbable Graft Stick 5x5x10mm