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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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TANDEM - 00885556019306

TANDEM BIPOLAR SHELL/XLPE LNR 42MM OD 22MM ID
Smith & Nephew, Inc.
71323042
Not in Commercial Distribution

  • 00885556019306 ()
71323042

  • Bipolar femoral head outer component, hemiarthroplasty

TANDEM - 00885556019139

TANDEM BIPOLAR SHELL/XLPE LNR 46MM OD 22MM ID
Smith & Nephew, Inc.
71323046
Not in Commercial Distribution

  • 00885556019139 ()
71323046

  • Bipolar femoral head outer component, hemiarthroplasty

TANDEM - 00885556018699

TANDEM BIPOLAR SHELL/XLPE LNR 50MM OD 22MM ID
Smith & Nephew, Inc.
71323050
Not in Commercial Distribution

  • 00885556018699 ()
71323050

  • Bipolar femoral head outer component, hemiarthroplasty

SPATIAL FRAME - 00885556057179

SPATIAL FRAME U PLATE 105MM ID W/ EXTRA HOLES
Smith & Nephew, Inc.
71932388
Not in Commercial Distribution

  • 00885556057179 ()
71932388

  • External orthopaedic fixation system, single-use

SPATIAL FRAME - 00885556056981

SPATIAL FRAME U PLATE 130MM ID W/ EXTRA HOLES
Smith & Nephew, Inc.
71932387
Not in Commercial Distribution

  • 00885556056981 ()
71932387

  • External orthopaedic fixation system, single-use

R3 - 00885556187814

R3 +4MM TRIAL LINER 36MM ID X 50MM OD
Smith & Nephew, Inc.
71934550
In Commercial Distribution

  • 00885556187814 ()
71934550

  • Acetabulum prosthesis trial, prefabricated, reusable

R3 - 00885556187760

R3 +4MM XLPE LINER 36MM ID X 50MM OD
Smith & Nephew, Inc.
71934549
In Commercial Distribution

  • 00885556187760 ()
71934549

  • Acetabulum prosthesis trial, prefabricated, reusable

SPATIAL FRAME - 00885556145616

SPATIAL FRAME U PLATE 80MM ID W/ EXTRA HOLES
Smith & Nephew, Inc.
71932386
Not in Commercial Distribution

  • 00885556145616 ()
71932386

  • External orthopaedic fixation system, single-use

R3 - 00885556085530

28MM ID X 44MM R3 LINER TRIAL 20 DEGREE
Smith & Nephew, Inc.
71934406
In Commercial Distribution

  • 00885556085530 ()
71934406

  • Acetabulum prosthesis trial, prefabricated, reusable

R3 - 00885556085486

28MM ID X 44MM R3 LINER TRIAL 0 DEGREE
Smith & Nephew, Inc.
71934405
In Commercial Distribution

  • 00885556085486 ()
71934405

  • Acetabulum prosthesis trial, prefabricated, reusable
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