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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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PS Tibial Insert, Size FG/4-9, 19mm thickness, Vitamin E UHMWPE
B-ONE ORTHO, CORP.
8821333519
In Commercial Distribution

  • 00843575105479 ()
8821333519

  • Posterior-stabilized total knee prosthesis
PS Tibial Insert, Size FG/4-9, 16mm thickness, Vitamin E UHMWPE
B-ONE ORTHO, CORP.
8821333516
In Commercial Distribution

  • 00843575105462 ()
8821333516

  • Posterior-stabilized total knee prosthesis
PS Tibial Insert, Size FG/4-9, 13mm thickness, Vitamin E UHMWPE
B-ONE ORTHO, CORP.
8821333513
In Commercial Distribution

  • 00843575105455 ()
8821333513

  • Posterior-stabilized total knee prosthesis
PS Tibial Insert, Size FG/4-9, 11mm thickness, Vitamin E UHMWPE
B-ONE ORTHO, CORP.
8821333511
In Commercial Distribution

  • 00843575105448 ()
8821333511

  • Posterior-stabilized total knee prosthesis
PS Tibial Insert, Size FG/4-9, 10mm thickness, Vitamin E UHMWPE
B-ONE ORTHO, CORP.
8821333510
In Commercial Distribution

  • 00843575105431 ()
8821333510

  • Posterior-stabilized total knee prosthesis
PS Tibial Insert, Size FG/4-9, 9mm thickness, Vitamin E UHMWPE
B-ONE ORTHO, CORP.
8821333509
In Commercial Distribution

  • 00843575105424 ()
8821333509

  • Posterior-stabilized total knee prosthesis
PS Tibial Insert, Size DE/3-7, 19mm thickness, Vitamin E UHMWPE
B-ONE ORTHO, CORP.
8821333319
In Commercial Distribution

  • 00843575105417 ()
8821333319

  • Posterior-stabilized total knee prosthesis
Diagnostic Cardiology Leadwire, Dedicated Banana AHA, 26 in / 66 cm, E
Carefusion Finland 320 Oy
2020558-014
Not in Commercial Distribution

  • 10885403260360 ()
2020558-014

  • Electrocardiographic lead set, reusable
ApeX-LNK Acetabular Insert, UHMWPE 10 degree Hood, E Insert/40mm ID
Omni Life Science, Inc.
H5-54840
In Commercial Distribution

  • 00841690120056 ()
H5-54840

  • Non-constrained polyethylene acetabular liner
ApeX-LNK Acetabular Insert, UHMWPE 10 degree Hood, E Insert/36mm ID
Omni Life Science, Inc.
H5-54836
In Commercial Distribution

  • 00841690120049 ()
H5-54836

  • Non-constrained polyethylene acetabular liner
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