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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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In2Bones - 00810021866840

Evans Wedge Sizer Assy - 20 X 20, Reusable
IN2BONES USA, LLC
C01 N1021
In Commercial Distribution

  • 00810021866840 ()
C01 N1021

  • Orthopaedic implant aiming arm

SIGNAFUSE Bioactive Bone Graft - 00816986020501

SIGNAFUSE Bioactive Bone Graft is a bioactive bone graft substitute comprising biphasic mineral granules and 45S5 bioactive glass suspended in a porous type I collagen matrix. The device is provided sterile and is to be combined with autologous bone marrow aspirate prior to use to facilitate packing into bony defects. The device provides an osteoconductive scaffold that resorbs and guides host bone regeneration during the healing process.
BIOVENTUS LLC
100X25X8 MM, 20 CC
In Commercial Distribution

  • 00816986020501 ()
SGFS-020

  • Synthetic bone graft

Dover - 10885380200915

100% SILICONE FOLEY CATHETER, COUDE TIP, 5 CC, 2-WAY, 20 FR (6.7 MM)
Cardinal Health 200, LLC
20520CW
In Commercial Distribution

  • 20885380200912 ()
  • 10885380200915 ()
  • 50885380200913 ()

  • Catheter Gauge: 20 French
20520CW

  • Indwelling urethral drainage balloon catheter, non-antimicrobial

Dover - 10192253066371

100% SILICONE SILVER-HYDROGEL COATED FOLEY CATHETER, 30 CC, 2-WAY, 20 FR (6.7 MM)
Cardinal Health 200, LLC
630203IC
In Commercial Distribution

  • 50192253066379 ()
  • 20192253066378 ()
  • 10192253066371 ()
630203IC

  • Indwelling urethral drainage balloon catheter, non-antimicrobial

Dover - 10192253066326

100% SILICONE SILVER-HYDROGEL COATED FOLEY CATHETER, 5 CC, 2-WAY, 20 FR (6.7 MM)
Cardinal Health 200, LLC
605205IC
In Commercial Distribution

  • 50192253066324 ()
  • 20192253066323 ()
  • 10192253066326 ()
605205IC

  • Indwelling urethral drainage balloon catheter, non-antimicrobial

Dover - 10192253058376

SILICONE ELASTOMER COATED LATEX FOLEY CATHETER, 30 CC, 2-WAY, 20 FR (6.7 MM)
Cardinal Health 200, LLC
403720
In Commercial Distribution

  • 20192253058373 ()
  • 10192253058376 ()
  • 50192253058374 ()
403720

  • Indwelling urethral drainage balloon catheter, non-antimicrobial

Dover - 10192253058321

SILICONE ELASTOMER COATED LATEX FOLEY CATHETER, 5 CC, 2-WAY, 20 FR (6.7 MM)
Cardinal Health 200, LLC
402720
In Commercial Distribution

  • 20192253058328 ()
  • 10192253058321 ()
  • 50192253058329 ()
402720

  • Indwelling urethral drainage balloon catheter, non-antimicrobial

Dover - 10192253031331

100% SILICONE SILVER-HYDROGEL COATED FOLEY CATHETER, 30 CC, 2-WAY, 20 FR (6.7 MM)
Cardinal Health 200, LLC
630203IC
Not in Commercial Distribution

  • 20192253031338 ()
  • 10192253031331 ()
630203IC

  • Indwelling urethral drainage balloon catheter, antimicrobial

Dover - 10192253031096

100% SILICONE SILVER-HYDROGEL COATED FOLEY CATHETER, 5 CC, 2-WAY, 20 FR (6.7 MM)
Cardinal Health 200, LLC
605205IC
Not in Commercial Distribution

  • 20192253031093 ()
  • 10192253031096 ()
605205IC

  • Indwelling urethral drainage balloon catheter, antimicrobial

Dover - 10192253027129

SILICONE ELASTOMER COATED LATEX FOLEY CATHETER, 30 CC, 3-WAY, 20 FR (6.7 MM)
Cardinal Health 200, LLC
8887689209
In Commercial Distribution

  • 20192253027126 ()
  • 10192253027129 ()
  • 50192253027127 ()
8887689209

  • Single-administration urethral drainage/irrigation catheter
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