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BIOVENTUS LLC 71034601 EXOGEN® Ultrasound Bone Healing System

Company Name
BIOVENTUS LLC
Catalog Number
71034601

Description

Replacement MOU for the EXOGEN® Ultrasound Bone Healing System, device identifier M937710346001.
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Summary

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Out of Stock
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71034600

BIOVENTUS LLC 71034600 EXOGEN® Ultrasound Bone Healing System

The EXOGEN device provides non-invasive therapy for healing non-unions and accelerating time to healing of fresh fractures. The EXOGEN Ultrasound Bone Healing Systems has been designed both for use with conservatively treated fresh fractures and non-unions or surgically treated non-unions. The device transmits a low intensity ultrasound signal to the fracture site through coupling gel, with little or no sensation felt by the patient during the treatment. The low-intensity pulsed ultrasound has been shown in in-vitro and in-vivo studies to stimulate cells to produce growth factors and proteins that are important to bone healing. The patient administers treatment at home or at work, once daily, for 20 minutes, or as prescribed by a physician. The device automatically alerts the patient in case of improper application or device performance. The EXOGEN Ultrasound Bone Healing System consists of one main operating unit, gel bottles and strap. The main operating unit provides the treatment control circuitry, the primary battery supply, and monitors the operation of the transducer at the fracture site. The signal specifications cannot be changed.
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Additional Details

Device Identifier
M937710346011
Is RX
Yes
Is Over the Counter
No
Requires Sterilization
No
Is Sterile
No
Is Single Use
Yes

Barcode Mapping

Unit of MeasurementEachesGTIN
Each1M937710346011