N-Force Blue IN050-5

GUDID 00889024563261

Etex Corporation

Synthetic bone graft

• Primary Device ID: 00889024563261
• NIH Device Record Key: ef331260-ff99-4a91-a96d-15a38411efce
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: N-Force Blue
• Version Model Number: IN050-5
• Catalog Number: IN050-5
• Company DUNS: 622221141
• Company Name: Etex Corporation
• 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: false
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 877-383-9276
• Email: etex.cs@zimmerbiomet.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024563261 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062630

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: 2019-02-28
• Device Publish Date: 2019-01-28

On-Brand Devices [N-Force Blue]

• 00889024563261: IN050-5
• 00889024563254: IN050-6