EquivaBone ®

GUDID 00889024205543

Etex Corporation

Synthetic bone graft

• Primary Device ID: 00889024205543
• NIH Device Record Key: 07666ef7-75b6-4092-a5f5-5ba0fa1e5297
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EquivaBone ®
• Version Model Number: 76-6022
• 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: true
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• 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: sales@etexcorp.com

Device Dimensions

• Total Volume: 10 Milliliter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store at 15-25 Degrees Celcius Keep Dry Keep Away From Sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024205543 [Primary]

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: 5
• Public Version Date: 2019-12-17
• Device Publish Date: 2015-10-24

On-Brand Devices [EquivaBone ® ]

• 00889024205550: 76-6041
• 00889024205543: 76-6022
• 00889024205536: 76-6021
• 00889024205529: 76-6027