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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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REV DISTAL STM, 16X140mm
Encore Medical, L.P.
428-16-140
In Commercial Distribution

  • 00888912023726 ()


  • Revision coated hip femur prosthesis
LIMA MODULAR REVISION HIP Revision Body, Lat.
Encore Medical, L.P.
428-01-080
In Commercial Distribution

  • 00888912023719 ()


  • Revision coated hip femur prosthesis
LIMA MODULAR REVISION HIP Revision Body, Lat.
Encore Medical, L.P.
428-01-070
In Commercial Distribution

  • 00888912023702 ()


  • Revision coated hip femur prosthesis
LIMA MODULAR REVISION HIP Revision Body, Lat.
Encore Medical, L.P.
428-01-060
In Commercial Distribution

  • 00888912023696 ()


  • Revision coated hip femur prosthesis
LIMA MODULAR REVISION HIP Revision Body, Std.
Encore Medical, L.P.
428-00-050
In Commercial Distribution

  • 00888912023689 ()


  • Revision coated hip femur prosthesis
REVELATION microMAX, REDUCED NECK, SZ 18.0 LEFT
Encore Medical, L.P.
427-41-180
In Commercial Distribution

  • 00888912023672 ()


  • Coated hip femur prosthesis, modular
REVELATION microMAX, STD. NECK, SZ 9.0 RIGHT
Encore Medical, L.P.
427-32-090
In Commercial Distribution

  • 00888912023665 ()


  • Coated hip femur prosthesis, modular
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
PINNACLE POROCOAT ACETABULAR SHELL 300 SERIES 66mm OD
DEPUY ORTHOPAEDICS, INC.
1217-03-066
In Commercial Distribution

  • 10603295008729 ()
121703066

  • Acetabular shell
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