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Support App (Palma)
Advanced Bionics, LLC
CI-6517
In Commercial Distribution
- 00840094491007 ()
- Audiometric/hearing device software
No Description
Advanced Bionics, LLC
CI-1600-04
In Commercial Distribution
- 00840094483156 ()
- Cochlear implant system electrode array assembly
No Description
Advanced Bionics, LLC
CI-1600-05
In Commercial Distribution
- 00840094481640 ()
- Cochlear implant system electrode array assembly
No Description
Advanced Bionics, LLC
CI-1410
- Cochlear implant system
No Description
Biomet Orthopedics, LLC
SSI005138
In Commercial Distribution
- 00889024572515 ()
- Left
SSI005138
- Orthopaedic inorganic implant inserter/extractor, reusable
No Description
Biomet Orthopedics, LLC
SSI005137
In Commercial Distribution
- 00889024572508 ()
- Right
SSI005137
- Orthopaedic inorganic implant inserter/extractor, reusable
No Description
BIOVENTUS LLC
71034660
In Commercial Distribution
- M937710346601 ()
- Personal device holder, single-use
Replacement MOU for the EXOGEN® Ultrasound Bone Healing System, device identifier M937710346001.
BIOVENTUS LLC
71034601
In Commercial Distribution
- M937710346011 ()
71034601
- Bone growth ultrasonic stimulator
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.
BIOVENTUS LLC
71034600
In Commercial Distribution
- M937710346001 ()
71034600
- Bone growth ultrasonic stimulator
- Radiographic image marker, manual
- Skin topical coupling gel
- Personal device holder, single-use
Replacement Main Operating Unit (MOU) for the EXOGEN Ultrasound Bone Healing System, device identifier M937710344001.
BIOVENTUS LLC
71034401
In Commercial Distribution
- M937710344011 ()
71034401
- Bone growth ultrasonic stimulator