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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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The EXOGEN Ultrasound Bone Healing System provides non-invasive therapy for healing non-unions and accelerating time to healing of fresh fractures. EXOGEN is designed both for use with conservatively treated fresh fractures and non-unions, or surgically-treated non-unions. EXOGEN 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. 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. EXOGEN automatically alerts the patient in case of improper application or performance. The EXOGEN Ultrasound Bone Healing System consists of one EXOGEN device, a charger, a gel bottle and strap. The EXOGEN device provides the treatment control circuitry, the battery supply and monitors the operation of the transducer at the fracture site. Thesignal specifications cannot be changed.
BIOVENTUS LLC
71034400
In Commercial Distribution

  • M937710344001 ()
71034400

  • Bone growth ultrasonic stimulator
  • Radiographic image marker, manual
  • Skin topical coupling gel
  • Personal device holder, single-use
  • Noninvasive device battery charger
Hospital Electronics System
CARDIOMEMS, INC.
CM3000
In Commercial Distribution

  • 05415067029331 ()
CM3000

  • Implantable pulmonary artery pressure monitoring system
Clinical Programmer Kit
ST. JUDE MEDICAL, INC.
MN10700
In Commercial Distribution

  • 05415067025593 ()
MN10700

  • Implantable spinal cord electrical stimulation system programmer
Patient Programmer Kit
ST. JUDE MEDICAL, INC.
MN10600-02
In Commercial Distribution

  • 05415067025586 ()
MN10600-02

  • Implantable spinal cord electrical stimulation system programmer
Trial Neurostimulator
ST. JUDE MEDICAL, INC.
MN10100
In Commercial Distribution

  • 05415067025494 ()
MN10100

  • Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator
Automated External Defibrillator
HEARTSINE TECHNOLOGIES LTD
SAM360P
In Commercial Distribution

  • 05060167129735 ()
360-STR-AS-GW

  • Non-rechargeable public automated external defibrillator
Automated External Defibrillator
HEARTSINE TECHNOLOGIES LTD
SAM 360P
In Commercial Distribution

  • 05060167120862 ()
360-STR-AS-AV

  • Non-rechargeable public automated external defibrillator
Automated External Defibrillator
HEARTSINE TECHNOLOGIES LTD
SAM 350P
In Commercial Distribution

  • 05060167120855 ()
350-STR-AS-AV

  • Non-rechargeable public semi-automated external defibrillator
Automated External Defibrillator
HEARTSINE TECHNOLOGIES LTD
SAM450P
In Commercial Distribution

  • 05060167120725 ()
450-STR-US-AV

  • Non-rechargeable public semi-automated external defibrillator
Automated External Defibrillator
HEARTSINE TECHNOLOGIES LTD
SAM 360P
In Commercial Distribution

  • 05060167120688 ()
360-STR-US-10

  • Non-rechargeable public automated external defibrillator
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