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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 - 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

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 - 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

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
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