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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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JUMPSTART, 2" X 5", SINGLE LAYER
ARTHREX, INC.
R0205-10
In Commercial Distribution

  • 00888867186484 ()
  • M150R0205100 ()
  • 10888867186481 ()
R0205-10

  • Exudate-absorbent dressing, non-gel, antimicrobial
iBalance HTO Trial, 5 deg, 6.5mm
ARTHREX, INC.
SP-13400-05
In Commercial Distribution

  • 00888867261518 ()
  • M150SP13400050 ()
SP-13400-05

  • Knee tibia prosthesis trial, reusable
Needle LL, 25G x 5/8"
Supply Line International Medical, LLC
N256251
In Commercial Distribution

  • G018N2562511 ()
  • G018N2562510 ()
  • G018N2562512 ()


  • Hypodermic needle, single-use
5" X 6" HELIX COMPOSITE LAYER
ARTHREX, INC.
ABS-4051
In Commercial Distribution

  • 00888867225336 ()
  • M150ABS40511 ()
  • 10888867225333 ()
ABS-4051

  • Exudate-absorbent dressing, non-gel, antimicrobial
UNIVERS APEX HUMERAL STEM, SIZE 5
ARTHREX, INC.
AR-9100-05S
In Commercial Distribution

  • 00888867228214 ()
  • M150AR910005S1 ()
AR-9100-05S

  • Total shoulder prosthesis
2" X 5" SINGLE CONTACT LAYER
ARTHREX, INC.
ABS-4025
In Commercial Distribution

  • 00888867225268 ()
  • M150ABS40251 ()
  • 10888867225265 ()
ABS-4025

  • Exudate-absorbent dressing, non-gel, antimicrobial
PLATE, POW, LOCKING, TI, 5 MM
ARTHREX, INC.
AR-8953-05
In Commercial Distribution

  • 00888867055179 ()
  • M150AR8953050 ()
AR-8953-05

  • Orthopaedic fixation plate, non-bioabsorbable
LOW PROFILE T-PLATE, 2.4MM, 5 HOLE
ARTHREX, INC.
AR-8952MT-05
In Commercial Distribution

  • 00888867054974 ()
  • M150AR8952MT050 ()
AR-8952MT-05

  • Orthopaedic fixation plate, non-bioabsorbable
CALCANEUS STEP PLATE, 5 MM STEP
ARTHREX, INC.
AR-8949-050
In Commercial Distribution

  • 00888867054257 ()
  • M150AR89490500 ()
AR-8949-050

  • Orthopaedic fixation plate, non-bioabsorbable
IBALANCE TKA TIBIAL TRAY SIZE 5
ARTHREX, INC.
AR-503-TTTF
In Commercial Distribution

  • 00888867106734 ()
  • M150AR503TTTF1 ()
AR-503-TTTF

  • Uncoated knee tibia prosthesis, metallic
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