AccuFill®

GUDID 00889024406476

Etex Corporation

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