BonVie+ EPBV-10ML

GUDID 00199284455788

BonVie+ is a sterile, single-use, osteoconductive bone void filler intended to fill bony voids or gaps in the extremities and pelvis. It is supplied as a kit that includes a calcium salt and polymer powder, a mixing solution, and a silicone mat with cavities to form granules of various sizes. As the device resorbs, new bone gradually grows into the space previously occupied by the implant and replaces it during the healing process.

ELUTE , INC.

Bone matrix implant, synthetic, non-antimicrobial

• Primary Device ID: 00199284455788
• NIH Device Record Key: e6741d7d-8d0d-4f4f-baae-1bfc9960f154
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BonVie+
• Version Model Number: EPBV-10ML
• Catalog Number: EPBV-10ML
• Company DUNS: 968551015
• Company Name: ELUTE , INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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: (801)-410-4330
• Email: info@elutinc.com
• Phone: (801)-410-4330
• Email: info@elutinc.com
• Phone: (801)-410-4330
• Email: info@elutinc.com
• Phone: (801)-410-4330
• Email: info@elutinc.com
• Phone: (801)-410-4330
• Email: info@elutinc.com
• Phone: (801)-410-4330
• Email: info@elutinc.com
• Phone: (801)-410-4330
• Email: info@elutinc.com
• Phone: (801)-410-4330
• Email: info@elutinc.com
• Phone: (801)-410-4330
• Email: info@elutinc.com
• Phone: (801)-410-4330
• Email: info@elutinc.com
• Phone: (801)-410-4330
• Email: info@elutinc.com
• Phone: (801)-410-4330
• Email: info@elutinc.com

Device Dimensions

• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00199284455788 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K250346

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: 2025-08-21
• Device Publish Date: 2025-08-13