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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 OL1000 and OL1000 SC BONE GROWTH STIMULATORS are indicated for the noninvasive treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones. A nonunion is considered to be established when the fracture site shows no visibly progressive signs of healing. The OL1000 and OL1000 SC are portable, battery powered, microprocessor-controlled, noninvasive bone growth stimulators. The device is worn by a patient for 30 minutes a day and provides local electromagnetic field treatment for a non-healing fracture. The device produces very low energy combined static and dynamic electromagnetic fields on the order of the earth’s magnetic field. The device has a push button that starts the treatment and an audible tone to notify the patient that a treatment has started or has ended. A liquid crystal display (LCD) is utilized to display the status of the device, e.g., treatment record, daily treatment time countdown.
DJO, LLC
OL1000 Single Coil Size 3
In Commercial Distribution

  • 00888912161763 ()
01-211-0003

  • Patient-worn bone growth electromagnetic stimulator
The OL1000 and OL1000 SC BONE GROWTH STIMULATORS are indicated for the noninvasive treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones. A nonunion is considered to be established when the fracture site shows no visibly progressive signs of healing. The OL1000 and OL1000 SC are portable, battery powered, microprocessor-controlled, noninvasive bone growth stimulators. The device is worn by a patient for 30 minutes a day and provides local electromagnetic field treatment for a non-healing fracture. The device produces very low energy combined static and dynamic electromagnetic fields on the order of the earth’s magnetic field. The device has a push button that starts the treatment and an audible tone to notify the patient that a treatment has started or has ended. A liquid crystal display (LCD) is utilized to display the status of the device, e.g., treatment record, daily treatment time countdown.
DJO, LLC
OL1000 Single Coil Size 2
In Commercial Distribution

  • 00888912161756 ()
01-211-0002

  • Patient-worn bone growth electromagnetic stimulator
The OL1000 and OL1000 SC BONE GROWTH STIMULATORS are indicated for the noninvasive treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones. A nonunion is considered to be established when the fracture site shows no visibly progressive signs of healing. The OL1000 and OL1000 SC are portable, battery powered, microprocessor-controlled, noninvasive bone growth stimulators. The device is worn by a patient for 30 minutes a day and provides local electromagnetic field treatment for a non-healing fracture. The device produces very low energy combined static and dynamic electromagnetic fields on the order of the earth’s magnetic field. The device has a push button that starts the treatment and an audible tone to notify the patient that a treatment has started or has ended. A liquid crystal display (LCD) is utilized to display the status of the device, e.g., treatment record, daily treatment time countdown.
DJO, LLC
OL1000 Single Coil Size 1
In Commercial Distribution

  • 00888912161749 ()
01-211-0001

  • Patient-worn bone growth electromagnetic stimulator
The OL1000 and OL1000 SC BONE GROWTH STIMULATORS are indicated for the noninvasive treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones. A nonunion is considered to be established when the fracture site shows no visibly progressive signs of healing. The OL1000 and OL1000 SC are portable, battery powered, microprocessor-controlled, noninvasive bone growth stimulators. The device is worn by a patient for 30 minutes a day and provides local electromagnetic field treatment for a non-healing fracture. The device produces very low energy combined static and dynamic electromagnetic fields on the order of the earth’s magnetic field. The device has a push button that starts the treatment and an audible tone to notify the patient that a treatment has started or has ended. A liquid crystal display (LCD) is utilized to display the status of the device, e.g., treatment record, daily treatment time countdown.
DJO, LLC
OL1000 Dual Coil
In Commercial Distribution

  • 00888912011488 ()
01-203-0001

  • Patient-worn bone growth electromagnetic stimulator
The DYCL series OPTIGUIDE® Fiber Optic Diffuser is a light delivery system consisting of a 400-micron coated silica laser fiber, a proximal SMA-type laser connector, and a distal light diffusing tip (1.65mm diameter).
Pinnacle Biologics, Inc.
250
In Commercial Distribution

  • 00376128000148 ()

  • Length: 5.0 Centimeter


  • Gastrointestinal photodynamic therapy laser beam guide
The DYCL series OPTIGUIDE® Fiber Optic Diffuser is a light delivery system consisting of a 400-micron coated silica laser fiber, a proximal SMA-type laser connector, and a distal light diffusing tip (1.65mm diameter).
Pinnacle Biologics, Inc.
240
In Commercial Distribution

  • 00376128000131 ()

  • Length: 4.0 Centimeter


  • Gastrointestinal photodynamic therapy laser beam guide
The DYCL series OPTIGUIDE® Fiber Optic Diffuser is a light delivery system consisting of a 400-micron coated silica laser fiber, a proximal SMA-type laser connector, and a distal light diffusing tip (1.65mm diameter).
Pinnacle Biologics, Inc.
230
In Commercial Distribution

  • 00376128000124 ()

  • Length: 3.0 Centimeter


  • Gastrointestinal photodynamic therapy laser beam guide
The DYCL series OPTIGUIDE® Fiber Optic Diffuser is a light delivery system consisting of a 400-micron coated silica laser fiber, a proximal SMA-type laser connector, and a distal light diffusing tip (1.65mm diameter).
Pinnacle Biologics, Inc.
225
In Commercial Distribution

  • 00376128000117 ()

  • Length: 2.5 Centimeter


  • Gastrointestinal photodynamic therapy laser beam guide
The DYCL series OPTIGUIDE® Fiber Optic Diffuser is a light delivery system consisting of a 400-micron coated silica laser fiber, a proximal SMA-type laser connector, and a distal light diffusing tip (1.65mm diameter).
Pinnacle Biologics, Inc.
220
In Commercial Distribution

  • 00376128000100 ()

  • Length: 2.0 Centimeter


  • Gastrointestinal photodynamic therapy laser beam guide
The DYCL series OPTIGUIDE® Fiber Optic Diffuser is a light delivery system consisting of a 400-micron coated silica laser fiber, a proximal SMA-type laser connector, and a distal light diffusing tip (1.65mm diameter).
Pinnacle Biologics, Inc.
215
In Commercial Distribution

  • 00376128000094 ()

  • Length: 1.5 Centimeter


  • Gastrointestinal photodynamic therapy laser beam guide
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