EXOGEN Metatarsal Strap

GUDID M937710346601

BIOVENTUS LLC

Personal device holder, single-use Personal device holder, single-use Personal device holder, single-use Personal device holder, single-use Personal device holder, single-use Personal device holder, single-use Personal device holder, single-use Personal device holder, single-use Personal device holder, single-use Personal device holder, single-use Personal device holder, single-use Personal device holder, single-use Personal device holder, single-use Personal device holder, single-use Personal device holder, single-use Personal device holder, single-use Personal device holder, single-use Personal device holder, single-use Personal device holder, single-use Personal device holder, single-use Personal device holder, single-use Personal device holder, single-use Personal device holder, single-use Personal device holder, single-use Personal device holder, single-use Personal device holder, single-use Personal device holder, single-use Personal device holder, single-use Personal device holder, single-use Personal device holder, single-use

• Primary Device ID: M937710346601
• NIH Device Record Key: 7792cffd-4aa9-4138-b775-3fe945794507
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EXOGEN Metatarsal Strap
• Version Model Number: 71034660
• Company DUNS: 078450878
• Company Name: BIOVENTUS LLC
• 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: false
• 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: 18008364080
• Email: ctservicescenter@bioventus.com
• Phone: 18008364080
• Email: ctservicescenter@bioventus.com
• Phone: 18008364080
• Email: ctservicescenter@bioventus.com
• Phone: 18008364080
• Email: ctservicescenter@bioventus.com
• Phone: 18008364080
• Email: ctservicescenter@bioventus.com
• Phone: 18008364080
• Email: ctservicescenter@bioventus.com
• Phone: 18008364080
• Email: ctservicescenter@bioventus.com
• Phone: 18008364080
• Email: ctservicescenter@bioventus.com
• Phone: 18008364080
• Email: ctservicescenter@bioventus.com
• Phone: 18008364080
• Email: ctservicescenter@bioventus.com
• Phone: 18008364080
• Email: ctservicescenter@bioventus.com
• Phone: 18008364080
• Email: ctservicescenter@bioventus.com
• Phone: 18008364080
• Email: ctservicescenter@bioventus.com
• Phone: 18008364080
• Email: ctservicescenter@bioventus.com
• Phone: 18008364080
• Email: ctservicescenter@bioventus.com
• Phone: 18008364080
• Email: ctservicescenter@bioventus.com
• Phone: 18008364080
• Email: ctservicescenter@bioventus.com
• Phone: 18008364080
• Email: ctservicescenter@bioventus.com
• Phone: 18008364080
• Email: ctservicescenter@bioventus.com
• Phone: 18008364080
• Email: ctservicescenter@bioventus.com
• Phone: 18008364080
• Email: ctservicescenter@bioventus.com
• Phone: 18008364080
• Email: ctservicescenter@bioventus.com
• Phone: 18008364080
• Email: ctservicescenter@bioventus.com
• Phone: 18008364080
• Email: ctservicescenter@bioventus.com
• Phone: 18008364080
• Email: ctservicescenter@bioventus.com
• Phone: 18008364080
• Email: ctservicescenter@bioventus.com
• Phone: 18008364080
• Email: ctservicescenter@bioventus.com
• Phone: 18008364080
• Email: ctservicescenter@bioventus.com
• Phone: 18008364080
• Email: ctservicescenter@bioventus.com
• Phone: 18008364080
• Email: ctservicescenter@bioventus.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M937710346601 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P900009

FDA Product Code

• LOF: Stimulator, Bone Growth, Non-Invasive

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-12-27
• Device Publish Date: 2021-12-17

Devices Manufactured by BIOVENTUS LLC

• 10389130444418 - SUPARTZ FX sodium hyaluronate: 2023-10-06 SUPARTZ FX (P980044) is indicated for treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respon
• M937710346601 - EXOGEN Metatarsal Strap: 2021-12-27
• M937710346601 - EXOGEN Metatarsal Strap: 2021-12-27
• 00816986020488 - SIGNAFUSE Bioactive Bone Graft: 2020-08-07 SIGNAFUSE Bioactive Bone Graft is a bioactive bone graft substitute comprising biphasic mineral granules and 45S5 bioactive glas
• 00816986020495 - SIGNAFUSE Bioactive Bone Graft: 2020-08-07 SIGNAFUSE Bioactive Bone Graft is a bioactive bone graft substitute comprising biphasic mineral granules and 45S5 bioactive glas
• 00816986020501 - SIGNAFUSE Bioactive Bone Graft: 2020-08-07 SIGNAFUSE Bioactive Bone Graft is a bioactive bone graft substitute comprising biphasic mineral granules and 45S5 bioactive glas
• 00816986020518 - SIGNAFUSE Bioactive Bone Graft: 2020-08-07 SIGNAFUSE Bioactive Bone Graft is a bioactive bone graft substitute comprising biphasic mineral granules and 45S5 bioactive glas
• 00816986020006 - SIGNAFUSE: 2020-03-20 Bioactive Bone Graft Putty
• 00816986020013 - SIGNAFUSE: 2020-03-20 Bioactive Bone Graft Putty