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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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ECLIPSE TRUNION 49MM, SLOTTED, TPS CaP4.
ARTHREX, INC.
AR-9301-49CPC
In Commercial Distribution

  • 00888867276178 ()
AR-9301-49CPC

  • Coated shoulder humeral stem prosthesis
ECLIPSE TRUNION 47MM, SLOTTED, TPS CaP
ARTHREX, INC.
AR-9301-47CPC
In Commercial Distribution

  • 00888867276161 ()
AR-9301-47CPC

  • Coated shoulder humeral stem prosthesis
ECLIPSE TRUNION 45MM, SLOTTED, TPS CaP
ARTHREX, INC.
AR-9301-45CPC
In Commercial Distribution

  • 00888867276154 ()
AR-9301-45CPC

  • Coated shoulder humeral stem prosthesis
ECLIPSE TRUNION 43MM, SLOTTED, TPS CaP
ARTHREX, INC.
AR-9301-43CPC
In Commercial Distribution

  • 00888867276147 ()
AR-9301-43CPC

  • Coated shoulder humeral stem prosthesis
ECLIPSE TRUNION 41MM, SLOTTED, TPS CaP
ARTHREX, INC.
AR-9301-41CPC
In Commercial Distribution

  • 00888867276130 ()
AR-9301-41CPC

  • Coated shoulder humeral stem prosthesis
ECLIPSE TRUNION 39MM, SLOTTED, TPS CaP
ARTHREX, INC.
AR-9301-39CPC
In Commercial Distribution

  • 00888867276123 ()
AR-9301-39CPC

  • Coated shoulder humeral stem prosthesis
ECLIPSE TRUNION 37MM, SLOTTED, TPS CaP
ARTHREX, INC.
AR-9301-37CPC
In Commercial Distribution

  • 00888867276116 ()
AR-9301-37CPC

  • Coated shoulder humeral stem prosthesis
TRUNION KIT FOR UNIVERS II
ARTHREX, INC.
AR-9100TK
In Commercial Distribution

  • 00888867134867 ()
  • M150AR9100TK2 ()
AR-9100TK

  • Uncoated shoulder humeral stem prosthesis
The SpinaLogic is a portable, battery powered, microcontrolled, noninvasive bone growth stimulator indicated as an adjunct electrical treatment to primary lumbar spinal fusion surgery for one or two levels. The SpinaLogic is available in one size.
DJO, LLC
Spinalogic
In Commercial Distribution

  • 00888912011495 ()
01-207-0007

  • 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
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