AccuFill®

GUDID 00889024406476

Etex Corporation

Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft

• Primary Device ID: 00889024406476
• NIH Device Record Key: 67c09151-a897-42b8-930e-9bdcc89853d9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AccuFill®
• Version Model Number: 201.030
• 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: 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(877)383-9276
• Email: sales@etexcorp.com
• Phone: +1(877)383-9276
• Email: sales@etexcorp.com
• Phone: +1(877)383-9276
• Email: sales@etexcorp.com
• Phone: +1(877)383-9276
• Email: sales@etexcorp.com
• Phone: +1(877)383-9276
• Email: sales@etexcorp.com
• Phone: +1(877)383-9276
• Email: sales@etexcorp.com
• Phone: +1(877)383-9276
• Email: sales@etexcorp.com
• Phone: +1(877)383-9276
• Email: sales@etexcorp.com
• Phone: +1(877)383-9276
• Email: sales@etexcorp.com
• Phone: +1(877)383-9276
• Email: sales@etexcorp.com
• Phone: +1(877)383-9276
• Email: sales@etexcorp.com
• Phone: +1(877)383-9276
• Email: sales@etexcorp.com
• Phone: +1(877)383-9276
• Email: sales@etexcorp.com

Device Dimensions

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024406476 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190814

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: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2022-09-14
• Device Publish Date: 2015-11-02

On-Brand Devices [AccuFill®]

• 00889024406476: 201.030
• 00889024205444: 201.050