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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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OMNI Hip - 00841690119470

Bipolar Head, 45mm OD, 28mm ID
Omni Life Science, Inc.
H3-82845
In Commercial Distribution

  • 00841690119470 ()
H3-82845

  • Bipolar femoral head outer component, hemiarthroplasty

OMNI Hip - 00841690119463

Bipolar Head, 44mm OD, 28mm ID
Omni Life Science, Inc.
H3-82844
In Commercial Distribution

  • 00841690119463 ()
H3-82844

  • Bipolar femoral head outer component, hemiarthroplasty

OMNI Hip - 00841690119456

Bipolar Head, 43mm OD, 22.225mm ID
Omni Life Science, Inc.
H3-82243
In Commercial Distribution

  • 00841690119456 ()
H3-82243

  • Bipolar femoral head outer component, hemiarthroplasty

OMNI Hip - 00841690119449

Bipolar Head, 42mm OD, 22.225mm ID
Omni Life Science, Inc.
H3-82242
In Commercial Distribution

  • 00841690119449 ()
H3-82242

  • Bipolar femoral head outer component, hemiarthroplasty

OMNI Hip - 00841690119432

Bipolar Head, 41mm OD, 22.225mm ID
Omni Life Science, Inc.
H3-82241
In Commercial Distribution

  • 00841690119432 ()
H3-82241

  • Bipolar femoral head outer component, hemiarthroplasty

OMNI Hip - 00841690119425

Bipolar Head, 40mm OD, 22.225mm ID
Omni Life Science, Inc.
H3-82240
In Commercial Distribution

  • 00841690119425 ()
H3-82240

  • Bipolar femoral head outer component, hemiarthroplasty

OMNI Hip - 00841690119418

Bipolar Head, 39mm OD, 22.225mm ID
Omni Life Science, Inc.
H3-82239
In Commercial Distribution

  • 00841690119418 ()
H3-82239

  • Bipolar femoral head outer component, hemiarthroplasty

OMNI Hip - 00841690119401

Bipolar Head, 38mm OD, 22.225mm ID
Omni Life Science, Inc.
H3-82238
In Commercial Distribution

  • 00841690119401 ()
H3-82238

  • Bipolar femoral head outer component, hemiarthroplasty

Trays - 00842102104886

Metal ID Tag for Container - Blue
FLEXBAR MACHINE CORPORATION
72245M
In Commercial Distribution

  • 00842102104886 ()
72245M

  • Device sterilization/disinfection container, reusable

BENCOX Hip System - 08806373853852

BENCOX ID CEMENTED STEM NO.2.5
Corentec Co., Ltd
01.05.102
In Commercial Distribution

  • 08806373853852 ()


  • Uncoated hip femur prosthesis, modular

Bencox Hip System - 08806373888748

Bencox ID stem Rasp No.11
Corentec Co., Ltd
01.55.011
In Commercial Distribution

  • 08806373888748 ()


  • Femoral stem prosthesis trial
  • Bone file/rasp, manual, reusable

Bencox Hip System - 08806373888731

Bencox ID stem Rasp No.10
Corentec Co., Ltd
01.55.010
In Commercial Distribution

  • 08806373888731 ()


  • Bone file/rasp, manual, reusable
  • Femoral stem prosthesis trial

Bencox Hip System - 08806373888724

Bencox ID stem Rasp No.9
Corentec Co., Ltd
01.55.009
In Commercial Distribution

  • 08806373888724 ()


  • Femoral stem prosthesis trial
  • Bone file/rasp, manual, reusable

Bencox Hip System - 08806373888717

Bencox ID stem Rasp No.8
Corentec Co., Ltd
01.55.008
In Commercial Distribution

  • 08806373888717 ()


  • Bone file/rasp, manual, reusable
  • Femoral stem prosthesis trial

Bencox Hip System - 08806373888700

Bencox ID stem Rasp No.7
Corentec Co., Ltd
01.55.007
In Commercial Distribution

  • 08806373888700 ()


  • Femoral stem prosthesis trial
  • Bone file/rasp, manual, reusable

Bencox Hip System - 08806373888694

Bencox ID stem Rasp No.6
Corentec Co., Ltd
01.55.006
In Commercial Distribution

  • 08806373888694 ()


  • Bone file/rasp, manual, reusable
  • Femoral stem prosthesis trial

Bencox Hip System - 08806373888687

Bencox ID stem Rasp No.5
Corentec Co., Ltd
01.55.005
In Commercial Distribution

  • 08806373888687 ()


  • Femoral stem prosthesis trial
  • Bone file/rasp, manual, reusable

Bencox Hip System - 08806373888670

Bencox ID stem Rasp No.4
Corentec Co., Ltd
01.55.004
In Commercial Distribution

  • 08806373888670 ()


  • Bone file/rasp, manual, reusable
  • Femoral stem prosthesis trial

Bencox Hip System - 08806373888663

Bencox ID stem Rasp No.3
Corentec Co., Ltd
01.55.003
In Commercial Distribution

  • 08806373888663 ()


  • Femoral stem prosthesis trial
  • Bone file/rasp, manual, reusable

Bencox Hip System - 08806373888656

Bencox ID stem Rasp No.2
Corentec Co., Ltd
01.55.002
In Commercial Distribution

  • 08806373888656 ()


  • Femoral stem prosthesis trial
  • Bone file/rasp, manual, reusable

Bencox Hip System - 08806373888649

Bencox ID stem Rasp No.1
Corentec Co., Ltd
01.55.001
In Commercial Distribution

  • 08806373888649 ()


  • Bone file/rasp, manual, reusable
  • Femoral stem prosthesis trial

BENCOX Hip System - 08806373832734

BENCOX ID CEMENTED STEM NO.11
Corentec Co., Ltd
01.05.111
In Commercial Distribution

  • 08806373832734 ()


  • Uncoated hip femur prosthesis, modular

BENCOX Hip System - 08806373832727

BENCOX ID CEMENTED STEM NO.9
Corentec Co., Ltd
01.05.109
In Commercial Distribution

  • 08806373832727 ()


  • Uncoated hip femur prosthesis, modular

BENCOX Hip System - 08806373832710

BENCOX ID CEMENTED STEM NO.7
Corentec Co., Ltd
01.05.107
In Commercial Distribution

  • 08806373832710 ()


  • Uncoated hip femur prosthesis, modular

BENCOX Hip System - 08806373832703

BENCOX ID CEMENTED STEM NO.5
Corentec Co., Ltd
01.05.105
In Commercial Distribution

  • 08806373832703 ()


  • Uncoated hip femur prosthesis, modular

BENCOX Hip System - 08806373832697

BENCOX ID CEMENTED STEM NO.3
Corentec Co., Ltd
01.05.103
In Commercial Distribution

  • 08806373832697 ()


  • Uncoated hip femur prosthesis, modular

Kyocera Medical Technologies, Inc. - 00841523126422

Trial / Sizer 50mm OD - 28mm ID
KYOCERA MEDICAL TECHNOLOGIES, INC.
A 400
In Commercial Distribution

  • 00841523126422 ()
2416-028-050

  • General internal orthopaedic fixation system implantation kit

Kyocera Medical Technologies, Inc. - 00841523126408

Trial / Sizer 48mm OD - 28mm ID
KYOCERA MEDICAL TECHNOLOGIES, INC.
A 400
In Commercial Distribution

  • 00841523126408 ()
2416-028-048

  • General internal orthopaedic fixation system implantation kit

Kyocera Medical Technologies, Inc. - 00841523126385

Trial / Sizer 46mm OD - 28mm ID
KYOCERA MEDICAL TECHNOLOGIES, INC.
A 400
In Commercial Distribution

  • 00841523126385 ()
2416-028-046

  • General internal orthopaedic fixation system implantation kit

Kyocera Medical Technologies, Inc. - 00841523126378

Trial / Sizer 45mm OD - 28mm ID
KYOCERA MEDICAL TECHNOLOGIES, INC.
A 400
In Commercial Distribution

  • 00841523126378 ()
2416-028-045

  • General internal orthopaedic fixation system implantation kit
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