Calcigen® S Bone Graft System 348012

GUDID 00887868284847

Biomet Biologics, LLC

Synthetic bone graft

• Primary Device ID: 00887868284847
• NIH Device Record Key: eacfeec4-13e5-4083-8f1b-90ee509dd56f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Calcigen® S Bone Graft System
• Version Model Number: 348012
• Catalog Number: 348012
• Company DUNS: 802003074
• Company Name: Biomet Biologics, 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

Customer Support Contacts

• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887868284847 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K013790

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: 2019-02-11
• Device Publish Date: 2019-01-11

On-Brand Devices [Calcigen® S Bone Graft System]

• 00887868284854: 348014
• 00887868284847: 348012
• 00887868284830: 348010