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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 BC/3-6, 13mm thickness, Vitamin E UHMWPE
B-ONE ORTHO, CORP.
8821333113
In Commercial Distribution

  • 00843575105332 ()
8821333113

  • Posterior-stabilized total knee prosthesis
PS Tibial Insert, Size BC/3-6, 11mm thickness, Vitamin E UHMWPE
B-ONE ORTHO, CORP.
8821333111
In Commercial Distribution

  • 00843575105325 ()
8821333111

  • Posterior-stabilized total knee prosthesis
PS Tibial Insert, Size A/1-4, 11mm thickness, Vitamin E UHMWPE
B-ONE ORTHO, CORP.
8821333011
In Commercial Distribution

  • 00843575105264 ()
8821333011

  • Posterior-stabilized total knee prosthesis
PS Tibial Insert, Size A/1-4, 10mm thickness, Vitamin E UHMWPE
B-ONE ORTHO, CORP.
8821333010
In Commercial Distribution

  • 00843575105257 ()
8821333010

  • Posterior-stabilized total knee prosthesis
PS Tibial Insert, Size A/1-4, 9mm thickness, Vitamin E UHMWPE
B-ONE ORTHO, CORP.
8821333009
In Commercial Distribution

  • 00843575105240 ()
8821333009

  • Posterior-stabilized total knee prosthesis
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
ApeX-LNK Acetabular Insert, UHMWPE 10 degree Hood, E Insert/32mm ID
Omni Life Science, Inc.
H5-54832
In Commercial Distribution

  • 00841690120032 ()
H5-54832

  • Non-constrained polyethylene acetabular liner
ApeX-LNK Acetabular Insert, UHMWPE 10 degree Hood, E Insert/28mm ID
Omni Life Science, Inc.
H5-54828
In Commercial Distribution

  • 00841690120025 ()
H5-54828

  • Non-constrained polyethylene acetabular liner
ApeX-LNK Acetabular Insert, UHMWPE 0 degree Hood, E Insert/40mm ID
Omni Life Science, Inc.
H5-44840
In Commercial Distribution

  • 00841690119906 ()
H5-44840

  • Non-constrained polyethylene acetabular liner
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