Signafuse SGF-150

GUDID 00852371006002

Bioactive Bone Graft Putty

BIOSTRUCTURES, LLC

Bone matrix implant, synthetic

• Primary Device ID: 00852371006002
• NIH Device Record Key: 60b8289f-f825-44de-bf7a-f0a3f0ae0318
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Signafuse
• Version Model Number: SGF-150
• Catalog Number: SGF-150
• 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	00852371006002 [Primary]

FDA Product Code

• MQV: Filler, Bone Void, Calcium Compound

Sterilization

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

[00852371006002]

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: 2015-12-21

On-Brand Devices [Signafuse]

• 00852371006026: Bioactive Bone Graft Putty
• 00852371006019: Bioactive Bone Graft Putty
• 00852371006002: Bioactive Bone Graft Putty