Osteofuse OF001

GUDID 00852371006033

Bioactive Bone Graft Putty

BIOSTRUCTURES, LLC

Bone matrix implant, synthetic

• Primary Device ID: 00852371006033
• NIH Device Record Key: 53fa2708-e6e1-4b91-b256-b6a0e6b92c7f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Osteofuse
• Version Model Number: OF001
• Catalog Number: OF001
• Company DUNS: 827042487
• Company Name: BIOSTRUCTURES, LLC
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852371006033 [Primary]

FDA Product Code

• MQV: Filler, Bone Void, Calcium Compound

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[00852371006033]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2015-11-16

Devices Manufactured by BIOSTRUCTURES, LLC

• 00852371006002 - Signafuse: 2018-03-29 Bioactive Bone Graft Putty
• 00852371006019 - Signafuse: 2018-03-29 Bioactive Bone Graft Putty
• 00852371006026 - Signafuse: 2018-03-29 Bioactive Bone Graft Putty
• 00852371006033 - Osteofuse: 2018-03-29Bioactive Bone Graft Putty
• 00852371006033 - Osteofuse: 2018-03-29 Bioactive Bone Graft Putty
• 00852371006088 - OsteoMatrix: 2018-03-29 Mineralized Collagen Scaffold
• 00852371006095 - OsteoMatrix: 2018-03-29 Mineralized Collagen Scaffold
• 00852371006101 - Silhouette: 2018-03-29 Mineralized Collagen Strip
• 00852371006118 - Silhouette: 2018-03-29 Mineralized Collagen Strip