Synthecure 50-003

GUDID 04262531220012

Heraeus Medical LLC

Bone matrix implant, synthetic, non-antimicrobial

• Primary Device ID: 04262531220012
• NIH Device Record Key: ed4f40b8-eaff-4173-8673-1b706a8eac21
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Synthecure
• Version Model Number: Bone Void Filler Kit, 5cc
• Catalog Number: 50-003
• Company DUNS: 080993690
• Company Name: Heraeus Medical 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	04262531220012 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K250141

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-08-08
• Device Publish Date: 2025-07-31

On-Brand Devices [Synthecure]

• 04262531220036: Bone Void Filler Kit, 20cc
• 04262531220029: Bone Void Filler Kit, 10cc
• 04262531220012: Bone Void Filler Kit, 5cc
• 04262531220005: Bone Void Filler Kit, 3cc