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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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APEX PS Knee - 00841690112150

PS femur, cemented Size 5 Right
Omni Life Science, Inc.
KP-0050R
In Commercial Distribution

  • 00841690112150 ()
KP-0050R

  • Uncoated knee femur prosthesis, metallic

APEX PS Knee - 00841690112143

PS femur, cemented Size 5 Left
Omni Life Science, Inc.
KP-0050L
In Commercial Distribution

  • 00841690112143 ()
KP-0050L

  • Uncoated knee femur prosthesis, metallic

APEX Knee System - 00841690111320

CR Femoral Trial Size 5 Right
Omni Life Science, Inc.
KS-1450R
In Commercial Distribution

  • 00841690111320 ()
KS-1450R

  • Knee femur prosthesis trial, reusable

APEX Knee System - 00841690111313

CR Femoral Trial Size 5 Left
Omni Life Science, Inc.
KS-1450L
In Commercial Distribution

  • 00841690111313 ()
KS-1450L

  • Knee femur prosthesis trial, reusable

APEX Knee System - 00841690110392

Tibial Tray Trial Size 5 Right
Omni Life Science, Inc.
WS-2115R
In Commercial Distribution

  • 00841690110392 ()
WS-2115R

  • Knee tibia prosthesis trial, reusable

APEX Knee System - 00841690110385

Tibial Tray Trial Size 5 Left
Omni Life Science, Inc.
WS-2115L
In Commercial Distribution

  • 00841690110385 ()
WS-2115L

  • Knee tibia prosthesis trial, reusable

APEX CR Knee - 00841690100898

CR Femoral Cemented, Size 5 Right
Omni Life Science, Inc.
KC-1105R
In Commercial Distribution

  • 00841690100898 ()
KC-1105R

  • Uncoated knee femur prosthesis, metallic

APEX CR Knee - 00841690100881

CR Femoral Cemented, Size 5 Left
Omni Life Science, Inc.
KC-1105L
In Commercial Distribution

  • 00841690100881 ()
KC-1105L

  • Uncoated knee femur prosthesis, metallic

OMNI K1 Hip - 00841690100102

K1 Femoral Stem, Size 5 Lat
Omni Life Science, Inc.
HC-00055
In Commercial Distribution

  • 00841690100102 ()
HC-00055

  • Coated hip femur prosthesis, modular

A. Titan Instruments - 00841685112332

Carver, PK-Thomas, Figure 5, 22 Handle
A. TITAN INSTRUMENTS, INC.
PKT-5 22
In Commercial Distribution

  • 00841685112332 ()


  • Dental restoration carver, amalgam, reusable
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