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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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Arthrex® - 00888867116900

iBALANCE TKA, PIN DRIVER
ARTHREX, INC.
AR-613-91
In Commercial Distribution

  • 00888867116900 ()
AR-613-91

  • Orthopaedic implant driver

Arthrex® - 00888867116894

iBALANCE TKA, STYLUS 2MM / 8MM
ARTHREX, INC.
AR-613-9
In Commercial Distribution

  • 00888867116894 ()
AR-613-9

  • Barmah Forest (BF) virus immunoglobulin M (IgM) antibody IVD, control

Arthrex® - 00888867116887

IBAL TKA,FEM TRL MOD RT SZ8
ARTHREX, INC.
AR-613-8R
In Commercial Distribution

  • 00888867116887 ()
AR-613-8R

  • Knee femur prosthesis trial, reusable

Arthrex® - 00888867116870

IBAL TKA,FEM TRL,MOD LFT SZ8
ARTHREX, INC.
AR-613-8L
In Commercial Distribution

  • 00888867116870 ()
AR-613-8L

  • Knee femur prosthesis trial, reusable

Arthrex® - 00888867116856

IBAL TKA,FEM TRL MOD RT SZ7
ARTHREX, INC.
AR-613-7R
In Commercial Distribution

  • 00888867116856 ()
AR-613-7R

  • Knee femur prosthesis trial, reusable

Arthrex® - 00888867116849

IBAL TKA,FEM TRL,MOD LFT SZ7
ARTHREX, INC.
AR-613-7L
In Commercial Distribution

  • 00888867116849 ()
AR-613-7L

  • Knee femur prosthesis trial, reusable

Arthrex® - 00888867116832

iBALANCE TKA, ANGEL WING
ARTHREX, INC.
AR-613-76
In Commercial Distribution

  • 00888867116832 ()
AR-613-76

  • Manual surgical saw blade, rigid

Arthrex® - 00888867116825

iBALANCE TKA, CROSS BAR, MODULAR
ARTHREX, INC.
AR-613-74
In Commercial Distribution

  • 00888867116825 ()
AR-613-74

  • Surgical drill guide, reusable

Arthrex® - 00888867116801

IBALANCE TKA, 2.45" HEADED THREADED PIN
ARTHREX, INC.
AR-613-72
In Commercial Distribution

  • 00888867116801 ()
AR-613-72

  • Surgical drill guide, reusable

Arthrex® - 00888867116795

IBALANCE TKA, FEMORAL PEG DRILL
ARTHREX, INC.
AR-613-70
In Commercial Distribution

  • 00888867116795 ()
AR-613-70

  • Surgical drill guide, reusable

Arthrex® - 00888867116788

IBALANCE TKA, 3" HEADLESS THREADED PIN
ARTHREX, INC.
AR-613-7
In Commercial Distribution

  • 00888867116788 ()
AR-613-7

  • Surgical drill guide, reusable

Arthrex® - 00888867116771

IBAL TKA,FEM TRL MOD RT SZ6
ARTHREX, INC.
AR-613-6R
In Commercial Distribution

  • 00888867116771 ()
AR-613-6R

  • Knee femur prosthesis trial, reusable

Arthrex® - 00888867116764

IBAL TKA,FEM TRL,MOD LFT SZ6
ARTHREX, INC.
AR-613-6L
In Commercial Distribution

  • 00888867116764 ()
AR-613-6L

  • Knee femur prosthesis trial, reusable

Arthrex® - 00888867116757

iBALANCE TKA, NOTCH CHISEL
ARTHREX, INC.
AR-613-69
In Commercial Distribution

  • 00888867116757 ()
AR-613-69

  • Orthopaedic implant impactor, reusable

Arthrex® - 00888867116740

iBALANCE TKA, CURVED OSTEOTOME
ARTHREX, INC.
AR-613-66
In Commercial Distribution

  • 00888867116740 ()
AR-613-66

  • Orthopaedic osteotome

Arthrex® - 00888867116733

iBALANCE TKA, DUAL SPIKE PUNCH
ARTHREX, INC.
AR-613-65
In Commercial Distribution

  • 00888867116733 ()
AR-613-65

  • Orthopaedic implant impactor, reusable

Arthrex® - 00888867116726

iBALANCE TKA, RASP
ARTHREX, INC.
AR-613-64
In Commercial Distribution

  • 00888867116726 ()
AR-613-64

  • Bone file/rasp, manual, reusable

Arthrex® - 00888867116672

ADJUSTMENT ROD
ARTHREX, INC.
AR-613-6
In Commercial Distribution

  • 00888867116672 ()
AR-613-6

  • Orthopaedic fixation implant alignment tool

Arthrex® - 00888867116665

IBAL TKA,FEM TRL MOD RT SZ5
ARTHREX, INC.
AR-613-5R
In Commercial Distribution

  • 00888867116665 ()
AR-613-5R

  • Knee femur prosthesis trial, reusable

Arthrex® - 00888867116405

IBAL TKA,FEM TRL MOD RT SZ3
ARTHREX, INC.
AR-613-3R
In Commercial Distribution

  • 00888867116405 ()
AR-613-3R

  • Knee femur prosthesis trial, reusable

Arthrex® - 00888867116399

IBAL TKA,FEM TRL,MOD LFT SZ3
ARTHREX, INC.
AR-613-3L
In Commercial Distribution

  • 00888867116399 ()
AR-613-3L

  • Knee femur prosthesis trial, reusable

Arthrex® - 00888867116382

iBALANCE TKA, SPACER BLOCK, 13MM
ARTHREX, INC.
AR-613-38
In Commercial Distribution

  • 00888867116382 ()
AR-613-38

  • Surgical drill guide, reusable

Arthrex® - 00888867116375

iBALANCE TKA, SPACER BLOCK, 12MM
ARTHREX, INC.
AR-613-37
In Commercial Distribution

  • 00888867116375 ()
AR-613-37

  • Surgical drill guide, reusable

Arthrex® - 00888867116368

iBALANCE TKA, SPACER BLOCK, 11MM
ARTHREX, INC.
AR-613-36
In Commercial Distribution

  • 00888867116368 ()
AR-613-36

  • Surgical drill guide, reusable

Arthrex® - 00888867116351

iBALANCE TKA, SPACER BLOCK, 10MM
ARTHREX, INC.
AR-613-35
In Commercial Distribution

  • 00888867116351 ()
AR-613-35

  • Surgical drill guide, reusable

Arthrex® - 00888867116344

iBALANCE TKA, SPACER BLOCK, 9MM
ARTHREX, INC.
AR-613-34
In Commercial Distribution

  • 00888867116344 ()
AR-613-34

  • Surgical drill guide, reusable

Arthrex® - 00888867116337

iBALANCE TKA, SPACER BLOCK, 8MM
ARTHREX, INC.
AR-613-33
In Commercial Distribution

  • 00888867116337 ()
AR-613-33

  • Surgical drill guide, reusable

Arthrex® - 00888867116320

iBALANCE TKA, SPACER BLOCK, +6MM
ARTHREX, INC.
AR-613-32
In Commercial Distribution

  • 00888867116320 ()
AR-613-32

  • Surgical drill guide, reusable

Arthrex® - 00888867116313

TIBIAL IMPACTOR
ARTHREX, INC.
AR-613-30
In Commercial Distribution

  • 00888867116313 ()
AR-613-30

  • Orthopaedic implant impactor, reusable

Arthrex® - 00888867116290

IBAL TKA,FEM TRL MOD RT SZ2
ARTHREX, INC.
AR-613-2R
In Commercial Distribution

  • 00888867116290 ()
AR-613-2R

  • Knee femur prosthesis trial, reusable
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