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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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LIQUIFIX FIX8, non-penetrating hernia mesh fixation, 40+ liquid anchors
ADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LIMITED
72014032
In Commercial Distribution

  • 05036912001427 ()
  • 05036912001410 ()
  • 05036912001434 ()


  • Surgical internal adhesive/sealant, synthetic polymer
TRANSCYTE® is a human fibroblast-derived temporary skin substitute consisting of a polymer membrane and donated neonatal human fibroblast cells cultured under aseptic conditions in vitro on a nylon mesh. Prior to cell growth, this nylon mesh is coated with porcine dermal collagen and bonded to a polymer membrane (silicone). This membrane provides a transparent synthetic epidermis when applied. As fibroblasts proliferate within the nylon mesh, they secrete human dermal collagen, matrix proteins and growth factors. Following freezing, no cellular metabolic activity remains; however, the tissue matrix and bound growth factors are left intact. The human fibroblast-derived temporary skin substitute provides a temporary protective barrier. TRANSCYTE is transparent and allows direct visual monitoring of the wound bed.
ORGANOGENESIS INC.
10633
In Commercial Distribution

  • 00618474000046 ()


  • Skin regeneration template, human-/animal-derived
Dermagraft is indicated for use in the treatment of full-thickness diabetic foot ulcers greater than six weeks duration, which extend through the dermis, but without tendon, muscle, joint capsule, or bone exposure. Dermagraft should be used in conjunction with standard wound care regimens and in patients that have adequate blood supply to the involved foot.
ORGANOGENESIS INC.
1
In Commercial Distribution

  • 00618474000015 ()


  • Skin regeneration template, human-/animal-derived
Apligraf is indicated for use with standard therapeutic compression for the treatment of non-infected partial and full thickness skin ulcers due to venous insufficience of greater than one month duration and which have not adequately responded to conventional ulcer therapy. Apligraf is also indicated for use with standard diabetic foot ulcer care for the treatment of full-thickness neuropathic diabetic foot ulcers of greater than three weeks duration which have not adequately responded to conventional ulcer therapy and which extend through the dermis but without tendon, muscle, capsule or bone exposure.
ORGANOGENESIS INC.
1
In Commercial Distribution

  • 00618474000008 ()


  • Skin regeneration template, human-/animal-derived
No Description
9902392 Canada Inc
024
Not in Commercial Distribution

  • 00627843737810 ()


  • Synovial fluid supplementation medium
Defibrillator ,MAIN, AED-1, 12 LEAD, SPO2/ETCO2/NIBP, BT/GPS, PACE, AC, NO RAILS, DMST
Zoll Medical Corporation
50011710030164013
In Commercial Distribution

  • 00847946099688 ()

  • 5.75" x 13.1" x 10.5"


  • Rechargeable professional automated external defibrillator
ONESTEP ADULT CPR SENSOR, SINGLE
Zoll Medical Corporation
8900-000350-01
In Commercial Distribution

  • 00847946099664 ()

  • 9.75" (w) X10.25" (l) X 1.5" (h)


  • Rechargeable professional automated external defibrillator
Defibrillator ,MAIN ASSY, X SERIES MONITOR/DEFIBRILLATOR 12 LEAD/W INTERP, NIBP, SPO2, SPCO, TEMP CPR EXPANSION PACK AND ETCO2, W/CP2, DMST
Zoll Medical Corporation
610-2131411-01
In Commercial Distribution

  • 00847946099657 ()

  • 8.9" x 10.4" x 8.75"


  • Physiologic-monitoring defibrillation system
ONESTEP CPR II MULTI-FUNCTION ELECTRODE, SINGLE
Zoll Medical Corporation
8900-000231-01
In Commercial Distribution

  • 00847946099640 ()

  • 8.5" (w) X 9.875" (l) X 1.5" (h)


  • Rechargeable professional automated external defibrillator
Defibrillator ,MAIN ASSY, PROPAQ MONITOR/DEFIBRILLATOR 12 LEAD/W INTERP, PACING, NIBP, SPO2, SPCO, SPMET, SpHb, SpOC, PVI, PI, IBP, TEMP CPR EXPANSION PACK AND ETCO2, W/CP2, DMST
Zoll Medical Corporation
310-2451312-01
In Commercial Distribution

  • 00847946099633 ()

  • 8.9" x 10.4" x 7.9"


  • Physiologic-monitoring defibrillation system
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