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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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iBalance TKA, Modular Tibial Tray, Sz 2
ARTHREX, INC.
AR-513-T2
In Commercial Distribution

  • 00888867187856 ()
  • M150AR513T21 ()
AR-513-T2

  • Uncoated knee tibia prosthesis, metallic
iBalance TKA, Modular Tibial Tray, Sz 1
ARTHREX, INC.
AR-513-T1
In Commercial Distribution

  • 00888867187849 ()
  • M150AR513T11 ()
AR-513-T1

  • Uncoated knee tibia prosthesis, metallic
RetroFusion Screw, 20mm
ARTHREX, INC.
AR-4157-20
In Commercial Distribution

  • 00888867187825 ()
AR-4157-20

  • Orthopaedic bone screw (non-sliding)
4MM CURVED TORPEDO
ARTHREX, INC.
AR-8400CTD
In Commercial Distribution

  • 10888867187808 ()
  • 00888867187801 ()
AR-8400CTD

  • Arthroscopic shaver system, electrically-powered
JUMPSTART, 4.0" DIA, HELIX COMP. LAYER
ARTHREX, INC.
HRD4IN-10
In Commercial Distribution

  • 00888867187146 ()
  • M150HRD4IN100 ()
  • 10888867187143 ()
HRD4IN-10

  • Exudate-absorbent dressing, non-gel, antimicrobial
JUMPSTART, 3.0" DIA, HELIX COMP. LAYER
ARTHREX, INC.
HRD3IN-10
In Commercial Distribution

  • 00888867187139 ()
  • M150HRD3IN100 ()
  • 10888867187136 ()
HRD3IN-10

  • Exudate-absorbent dressing, non-gel, antimicrobial
JUMPSTART, 2.5" DIA., HELIX COMP. LAYER
ARTHREX, INC.
HRD25IN-10
In Commercial Distribution

  • 00888867187122 ()
  • M150HRD25IN100 ()
  • 10888867187129 ()
HRD25IN-10

  • Exudate-absorbent dressing, non-gel, antimicrobial
JUMPSTART, 4.5" X 10", HELIX COMP. LAYER
ARTHREX, INC.
HR4510-05
In Commercial Distribution

  • 00888867186972 ()
  • M150HR4510050 ()
  • 10888867186979 ()
HR4510-05

  • Exudate-absorbent dressing, non-gel, antimicrobial
JUMPSTART, 1" X 1", SINGLE LAYER
ARTHREX, INC.
R0101F-10
In Commercial Distribution

  • 00888867186736 ()
  • M150R0101F100 ()
  • 10888867186733 ()
R0101F-10

  • Exudate-absorbent dressing, non-gel, antimicrobial
JUMPSTART, 4" X 4", HELIX COMP. LAYER
ARTHREX, INC.
HR0404-05
In Commercial Distribution

  • 00888867186590 ()
  • M150HR0404050 ()
  • 10888867186597 ()
HR0404-05

  • Exudate-absorbent dressing, non-gel, antimicrobial
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