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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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Power Control Console, Spanish Voice
OSTEOMED LLC
450-0021-03
In Commercial Distribution

  • 00845694012188 ()
450-0021-03

  • General internal orthopaedic fixation system implantation kit
Power Control Console, Italian Voice
OSTEOMED LLC
450-0021-02
In Commercial Distribution

  • 00845694012171 ()
450-0021-02

  • General internal orthopaedic fixation system implantation kit
Power Control Console 2, English Voice
OSTEOMED LLC
450-0021-01
In Commercial Distribution

  • 00845694012164 ()
450-0021-01

  • General internal orthopaedic fixation system implantation kit
Power Control Console 2
OSTEOMED LLC
450-0021-00
In Commercial Distribution

  • 00845694012157 ()
450-0021-00

  • General internal orthopaedic fixation system implantation kit
Power Control Console with Irrigation, Spanish Voice
OSTEOMED LLC
450-0005-03
In Commercial Distribution

  • 00845694012140 ()
450-0005-03

  • General internal orthopaedic fixation system implantation kit
Power Control Console with Irrigation, Italian Voice
OSTEOMED LLC
450-0005-02
In Commercial Distribution

  • 00845694012133 ()
450-0005-02

  • General internal orthopaedic fixation system implantation kit
Power Control Console 2i with Irrigation, English Voice
OSTEOMED LLC
450-0005-01
In Commercial Distribution

  • 00845694012126 ()
450-0005-01

  • General internal orthopaedic fixation system implantation kit
Power Control Console 2i with Irrigation
OSTEOMED LLC
450-0005-00
In Commercial Distribution

  • 00845694012119 ()
450-0005-00

  • General internal orthopaedic fixation system implantation kit
KobyGard Flex Tip Instrument
OSTEOMED LLC
380-0014
In Commercial Distribution

  • 00845694011952 ()

  • Length: 117 Millimeter
380-0014

  • General internal orthopaedic fixation system implantation kit
Fascia Separator
OSTEOMED LLC
380-0013
In Commercial Distribution

  • 00845694011945 ()

  • Length: 178 Millimeter
380-0013

  • General internal orthopaedic fixation system implantation kit
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