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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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• 2-ply pads • Saturated with 70% isopropyl alcohol • 100 individually packed alcohol pads per box • For external use only
HOME AIDE DIAGNOSTICS, INC.
1
In Commercial Distribution

  • 10850632007758 ()
  • 00850632007751 ()


  • Skin cleaning wipe
• 2-ply pads • Saturated with 70% isopropyl alcohol • 100 individually packed alcohol pads per box • For external use only
HOME AIDE DIAGNOSTICS, INC.
7331
In Commercial Distribution

  • 10850632007338 ()
  • 00850632007331 ()


  • Skin cleaning wipe
• 2-ply pads • Saturated with 70% isopropyl alcohol • 100 individually packed alcohol pads per box • For external use only
HOME AIDE DIAGNOSTICS, INC.
ALC100
In Commercial Distribution

  • 10850632007154 ()
  • 00850632007157 ()


  • Skin cleaning wipe
• 2-ply pads • Saturated with 70% isopropyl alcohol • 100 individually packed alcohol pads per box • For external use only
HOME AIDE DIAGNOSTICS, INC.
7034
In Commercial Distribution

  • 10850632007031 ()
  • 00850632007034 ()


  • Skin cleaning wipe
CAVUX Facet Fixation System (CAVUX FFS) is an integrated construct comprised of a CAVUX Cage and a single ALLY Bone Screw. CAVUX FFS is placed bilaterally through a posterior surgical approach and spans the interspace with points of fixation at each end of the construct. CAVUX FFS is intended for temporary stabilization as an adjunct to posterior cervical fusion in skeletally mature patients. CAVUX FFS is indicated for patients requiring a revision for an anterior pseudarthrosis at one level, from C3 to C7, with autogenous and/or allogenic bone graft.
Providence Medical Technology, Inc.
DX-31-404
In Commercial Distribution

  • 00852776006607 ()


  • Implantable cervical facet joint distractor
CAVUX Facet Fixation System (CAVUX FFS) is an integrated construct comprised of a CAVUX Cage and a single ALLY Bone Screw. CAVUX FFS is placed bilaterally through a posterior surgical approach and spans the interspace with points of fixation at each end of the construct. CAVUX FFS is intended for temporary stabilization as an adjunct to posterior cervical fusion in skeletally mature patients. CAVUX FFS is indicated for patients requiring a revision for an anterior pseudarthrosis at one level, from C3 to C7, with autogenous and/or allogenic bone graft.
Providence Medical Technology, Inc.
DX-31-403
In Commercial Distribution

  • 00852776006591 ()


  • Implantable cervical facet joint distractor
INTEGRA, ROUND BE SHAPE, SMOOTH SURFACE, SINGLE STAGE, REMOTE PORT TISSUE EXPANDER
PMT CORPORATION
3612-74
In Commercial Distribution

  • 00650551147930 ()

  • Total Volume: 1300 Milliliter
  • Length: 17 Centimeter
  • Width: 17 Centimeter


  • Skin-port tissue expander
INTEGRA, ROUND BE SHAPE, SMOOTH SURFACE, SINGLE STAGE, REMOTE PORT TISSUE EXPANDER
PMT CORPORATION
3612-70
In Commercial Distribution

  • 00650551147923 ()

  • Total Volume: 1600 Milliliter
  • Length: 16 Centimeter
  • Width: 16 Centimeter


  • Skin-port tissue expander
INTEGRA, ANATOMICAL TEARDROP SHAPE, SMOOTH SURFACE, SINGLE STAGE, INTERNAL PORT TISSUE EXPANDER
PMT CORPORATION
3612-63A-IR
In Commercial Distribution

  • 00650551147893 ()

  • Total Volume: 650 Milliliter
  • Length: 12.5 Centimeter
  • Width: 13.5 Centimeter


  • Skin-port tissue expander
INTEGRA, LOW HEIGHT BE SHAPE, SMOOTH SURFACE, SINGLE STAGE, INTERNAL PORT TISSUE EXPANDER
PMT CORPORATION
3611-14-IR
In Commercial Distribution

  • 00650551147886 ()

  • Total Volume: 530 Milliliter
  • Length: 14 Centimeter
  • Width: 12 Centimeter


  • Skin-port tissue expander
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