Silhouette SIL-180

GUDID 00852371006101

Mineralized Collagen Strip

BIOSTRUCTURES, LLC

Bone matrix implant, synthetic

• Primary Device ID: 00852371006101
• NIH Device Record Key: 8e41593d-11fc-4516-89d6-c620b8211e21
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Silhouette
• Version Model Number: SIL-180
• Catalog Number: SIL-180
• 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	00852371006101 [Primary]

FDA Product Code

• MQV: Filler, Bone Void, Calcium Compound

Sterilization

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

[00852371006101]

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 [Silhouette]

• 00852371006118: Mineralized Collagen Strip
• 00852371006101: Mineralized Collagen Strip