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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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4CIS® Poly Axial Bone Screw Driver I-Handle
ALPHANOX CO.,LTD.
4901-8058
In Commercial Distribution

  • 08800033336051 ()
4901-8058

  • Internal spinal fixation procedure kit, reusable
4CIS® Pinehurst Drill 20mm
ALPHANOX CO.,LTD.
5932-1212
In Commercial Distribution

  • 08800033336020 ()
5932-1212

  • External spinal fixation system
4CIS® Pinehurst Drill 18mm
ALPHANOX CO.,LTD.
5932-1211
In Commercial Distribution

  • 08800033336013 ()
5932-1211

  • External spinal fixation system
4CIS® Chiron-XT Nut Starter Square type
ALPHANOX CO.,LTD.
4901-8063
In Commercial Distribution

  • 08800033335931 ()
4901-8063

  • External spinal fixation system
4CIS® Chiron-XT Nut Screw Dinal Driver T-handle
ALPHANOX CO.,LTD.
4901-8062
In Commercial Distribution

  • 08800033335924 ()
4901-8062

  • External spinal fixation system
4CIS® Chiron XT Nut Screw Final Driver
ALPHANOX CO.,LTD.
4901-8061
In Commercial Distribution

  • 08800033335917 ()
4901-8061

  • External spinal fixation system
4CIS® Chiron-XT Nut Starter T-handle
ALPHANOX CO.,LTD.
4901-8060
In Commercial Distribution

  • 08800033335900 ()
4901-8060

  • External spinal fixation system
4CIS® Chiron XT Nut Starter
ALPHANOX CO.,LTD.
4901-8059
In Commercial Distribution

  • 08800033335894 ()
4901-8059

  • External spinal fixation system
4CIS® Torque Stabilizer
ALPHANOX CO.,LTD.
4901-8044
In Commercial Distribution

  • 08800033335887 ()
4901-8044

  • External spinal fixation system
4CIS® Closed Ring
ALPHANOX CO.,LTD.
4901-8042
In Commercial Distribution

  • 08800033335870 ()
4901-8042

  • External spinal fixation system
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