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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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RELIANCE LITe - 07613327263756

BONE FUNNEL PLUNGER
Stryker Corporation
48065500
In Commercial Distribution

  • 07613327263756 ()
48065500

  • Orthopaedic cement preparation/delivery kit

AutoPlex - 04546540593108

System without Needles and Cement
STRYKER CORPORATION
0605887000
In Commercial Distribution

  • 34546540593109 ()
  • 04546540593108 ()
0605887000

  • Orthopaedic cement preparation/delivery kit

MEDINAUT-Ix - 08809544170024

No Description
IMEDICOM CO., LTD.
MIX-EX4D
In Commercial Distribution

  • 08800038026292 ()
  • 08809544170024 ()


  • Orthopaedic cement preparation/delivery kit

MEDINAUT-Ix - 08809544170017

No Description
IMEDICOM CO., LTD.
MIX-EX4B
In Commercial Distribution

  • 08800038026285 ()
  • 08809544170017 ()


  • Orthopaedic cement preparation/delivery kit

MEDINAUT-Ix - 08809544170000

No Description
IMEDICOM CO., LTD.
MIX-EX4T
In Commercial Distribution

  • 08800038026278 ()
  • 08809544170000 ()


  • Orthopaedic cement preparation/delivery kit

Revolution - 04546540447913

Cement Mixing System with Femoral Breakaway Nozzle and Advanced Femoral Canal Pressurizer (Medium)
STRYKER CORPORATION
0606593000
In Commercial Distribution

  • 34546540447914 ()
  • 04546540447913 ()
0606593000

  • Orthopaedic cement preparation/delivery kit

Revolution - 04546540912343

Cement Mixing System with Femoral Breakaway Nozzle, Medium Solid Proximal Pressurizer, Universal Cement Restrictor with Disposable Inserter and Small Cement Restrictor
STRYKER CORPORATION
0606705000
In Commercial Distribution

  • 34546540912344 ()
  • 04546540912343 ()
0606-705-000

  • Orthopaedic cement preparation/delivery kit

PCD - 04546540907035

Precision System with Needle
STRYKER CORPORATION
0506485000
Not in Commercial Distribution

  • 34546540907036 ()
  • 04546540907035 ()

  • Needle Gauge: 13.0 Gauge
0506-485-000

  • Orthopaedic cement preparation/delivery kit

PCD - 04546540907011

Precision System with Needle
STRYKER CORPORATION
0506483000
Not in Commercial Distribution

  • 34546540907012 ()
  • 04546540907011 ()

  • Needle Gauge: 11.0 Gauge
0506-483-000

  • Orthopaedic cement preparation/delivery kit

PCD - 04546540906991

Precision System with Needle
STRYKER CORPORATION
0506482000
Not in Commercial Distribution

  • 34546540906992 ()
  • 04546540906991 ()

  • Needle Gauge: 10.0 Gauge
0506-482-000

  • Orthopaedic cement preparation/delivery kit
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