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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Epicel (cultured epidermal autografts) is an aseptically processed wound dressing composed of the patient’s own (autologous) keratinocytes grown ex vivo in the presence of proliferation-arrested, murine (mouse) fibroblasts. Epicel consists of sheets of proliferative, autologous keratinocytes, ranging from 2 to 8 cell layers thick and is referred to as a cultured epidermal autograft. Each graft of Epicel is attached to petrolatum gauze backing with titanium surgical clips and measures approximately 50 cm2 in area. Epicel is authorized by Federal law for use in adult and pediatric patients who have deep dermal or full-thickness burns comprising a total body surface area greater than or equal to 30%. Epicel may be used in conjunction with split-thickness autografts, or alone in patients for whom split-thickness autografts may not be an option due to the severity and extent of their burns.
VERICEL CORPORATION
0
In Commercial Distribution

  • W41020AU201P0001 ()

  • Area/Surface Area: 50 Square centimeter


  • Cultured skin autograft/xenograft
microTargeting(TM) Electrodes, 5x, Sterile, Single or Array, 1 Meg, for use with NexFrame and mT Drive or NexDrive.
FHC, INC.
FC5000-00755
In Commercial Distribution

  • 10873263007553 ()
  • 00873263007556 ()

  • Length: 10 Millimeter
  • Impedance: Megaohms
  • Length: 0.56 Millimeter
  • Length: 234.2 Millimeter
  • Length: 249.2 Millimeter
FC5000

  • Depth electrode
microTargeting Differential Electrodes 5x, Sterile, Single and Array, DZAP(L), T=30 for use with Nexframe and STar Drive
FHC, INC.
FC2004-00752
In Commercial Distribution

  • 10873263007522 ()
  • 00873263007525 ()

  • Length: 227.2 Millimeter
  • Outer Diameter: 0.56 Millimeter
  • Length: 242.2 Millimeter
  • Length: 10 Millimeter
  • Impedance: Megaohms
FC2004

  • Depth electrode
microTargeting Differential Electrode 5x, Sterile, Single and Array, D.ZAP(L) , T=30 for use with NexFrame and MT Drive or NexDrive
FHC, INC.
FC2003-00751
In Commercial Distribution

  • 10873263007515 ()
  • 00873263007518 ()

  • Length: 10 Millimeter
  • Length: 249.2 Millimeter
  • Length: 234.2 Millimeter
  • Outer Diameter: 0.56 Millimeter
  • Impedance: Megaohms
FC2003

  • Depth electrode
microTargeting D.ZAP(L) Differential Electrode 5x, Sterile, Single, T=30 for use with Frame and STar or MT Drive
FHC, INC.
FC2002-00750
In Commercial Distribution

  • 10873263007508 ()
  • 00873263007501 ()

  • Length: 10 Millimeter
  • Impedance: Megaohms
  • Length: 271.4 Millimeter
  • Length: 256.4 Millimeter
  • Outer Diameter: 0.77 Millimeter
FC2002

  • Depth electrode
microTargeting Differential Electrode 5x, D.ZAP(L), Sterile, Array, T=30 for use with Frame, STar or MT Drive
FHC, INC.
FC2001-00749
In Commercial Distribution

  • 10873263007492 ()
  • 00873263007495 ()

  • Length: 276.5 Millimeter
  • Outer Diameter: 0.55 Millimeter
  • Length: 261.5 Millimeter
  • Length: 10 Millimeter
  • Impedance: Megaohms
FC2001

  • Depth electrode
microTargeting Electrode 5x, non-sterile, Array, 1 Meg, T=30 for use with Frame, STar or MT Drive
FHC, INC.
FC1003-00748
In Commercial Distribution

  • 10873263007485 ()
  • 00873263007488 ()

  • Length: 10 Millimeter
  • Length: 276.5 Millimeter
  • Length: 261.5 Millimeter
  • Impedance: Megaohms
  • Outer Diameter: 0.55 Millimeter
FC1003

  • Depth electrode
microTargeting Electrode 5x, non-sterile, Single, 1 Meg, T=30 for use with Frame, STar or MT Drive
FHC, INC.
FC1002-00747
In Commercial Distribution

  • 10873263007478 ()
  • 00873263007471 ()

  • Outer Diameter: 0.77 Millimeter
  • Length: 10 Millimeter
  • Length: 256.4 Millimeter
  • Impedance: Megaohms
  • Length: 271.4 Millimeter
FC1002

  • Depth electrode
microTargeting Differential Electrode 5x, Sterile, Single, 1 Meg, T=30 for use with frame, STar or MT Drive
FHC, INC.
34680-00746
In Commercial Distribution

  • 10873263007461 ()
  • 00873263007464 ()

  • Length: 256.4 Millimeter
  • Impedance: Megaohms
  • Length: 271.4 Millimeter
  • Outer Diameter: 0.77 Millimeter
  • Length: 10 Millimeter
34680

  • Depth electrode
microTargeting Differential Electrode 5x, Sterile, Array, 1 Meg, T=30 for use with frame, STar or MT Drive
FHC, INC.
22670-00745
In Commercial Distribution

  • 10873263007454 ()
  • 00873263007457 ()

  • Length: 276.5 Millimeter
  • Outer Diameter: 0.55 Millimeter
  • Impedance: Megaohms
  • Length: 10 Millimeter
  • Length: 261.5 Millimeter
22670

  • Depth electrode
microTargeting™ Electrode, differential, tungsten, nonsterile
FHC, INC.
MTDWXN(AR)(MP1)-00744
In Commercial Distribution

  • 10873263007447 ()
  • 00873263007440 ()

  • Lumen/Inner Diameter: 0.55 Millimeter
  • Length: 220.72 Millimeter
  • Length: 205.72 Millimeter
  • Length: 10 Millimeter
MTDWXN(AR)(MP1)

  • Depth electrode
microTargeting Electrode, differential, tungsten, non-sterile
FHC, INC.
MTDWBN(AR)(DB1)-00742
In Commercial Distribution

  • 10873263007423 ()
  • 00873263007426 ()

  • Outer Diameter: 0.55 Millimeter
  • Impedance: Megaohms
  • Length: 234.22 Millimeter
  • Length: 249.22 Millimeter
  • Length: 10 Millimeter
MTDWBN(AR)(DB1)

  • Depth electrode
microTargeting(TM) Electrode, 6x, differential, tungsten, DZAP(Z), nonsterile
FHC, INC.
MTDWLN(AR)(DU1)-00707
In Commercial Distribution

  • 10873263007072 ()
  • 00873263007075 ()

  • Outer Diameter: 0.55 Millimeter
  • Length: 10 Millimeter
  • Impedance: Megaohms
  • Length: 271.5 Millimeter
  • Length: 286.5 Millimeter
MTDWLN(AR)(DU1)

  • Depth electrode
microTargeting(TM) Electrode, 6x, differential, tungsten, DZAP(Z), nonsterile
FHC, INC.
MTDWZN(AR)(DU1)-00706
In Commercial Distribution

  • 10873263007065 ()
  • 00873263007068 ()

  • Length: 271.5 Millimeter
  • Outer Diameter: 0.55 Millimeter
  • Length: 10 Millimeter
  • Length: 286.5 Millimeter
  • Impedance: Megaohms
MTDWZN(AR)(DU1)

  • Depth electrode
microTargeting(TM) Electrode, Back loaded, Platinum/Iridium with Glass Insulation
FHC, INC.
MTBPBN(DT1)-00671
In Commercial Distribution

  • 10873263006716 ()
  • 00873263006719 ()

  • Length: 300 Millimeter
  • Length: 10 Millimeter
  • Impedance: Megaohms
  • Outer Diameter: 0.63 Millimeter
MTBPBN(DT1)

  • Depth electrode
microTargeting Electrode, differential, 5mm ext, tungsten, non-sterile
FHC, INC.
MTDWBN(SP)(BW1)-00670
In Commercial Distribution

  • 10873263006709 ()
  • 00873263006702 ()

  • Length: 5 Millimeter
  • Length: 266.5 Millimeter
  • Impedance: Megaohms
  • Outer Diameter: 0.55 Millimeter
  • Length: 276.5 Millimeter
MTDWBN(SP)(BW1)

  • Depth electrode
microTargeting™ Electrodes, differential, tungsten, non-sterile, DZAP
FHC, INC.
MTDWZN(SS)(BP8)-00660
In Commercial Distribution

  • 10873263006600 ()
  • 00873263006603 ()

  • Outer Diameter: 0.7 Millimeter
  • Length: 3 Millimeter
  • Impedance: Megaohms
  • Length: 263.4 Millimeter
  • Length: 268.4 Millimeter
MTDWZN(SS)(BP8)

  • Depth electrode
microTargeting™ Electrodes, differential, tungsten, non-sterile, LZAP
FHC, INC.
MTDWLN(SS)(BP8)-00658
In Commercial Distribution

  • 10873263006587 ()
  • 00873263006580 ()

  • Length: 3 Millimeter
  • Impedance: Megaohms
  • Length: 268.4 Millimeter
  • Length: 263.4 Millimeter
  • Outer Diameter: 0.7 Millimeter
MTDWLN(SS)(BP8)

  • Depth electrode
microTargeting™ Electrode, back loaded, non sterile, platinum/iridium
FHC, INC.
MTBPLN(KB1)-00657
In Commercial Distribution

  • 10873263006570 ()
  • 00873263006573 ()

  • Outer Diameter: 0.63 Millimeter
  • Impedance: Megaohms
  • Length: 30 Millimeter
  • Length: 305 Millimeter
MTBPLN(KB1)

  • Depth electrode
microTargeting™ Electrode, back loaded, non sterile, tungsten
FHC, INC.
MTBWLN(ZK1)-00656
In Commercial Distribution

  • 10873263006563 ()
  • 00873263006566 ()

  • Outer Diameter: 0.62 Millimeter
  • Length: 2 Millimeter
  • Length: 250 Millimeter
MTBWLN(ZK1)

  • Depth electrode
microTargeting™ Electrode, differential, platinum/iridium, nonsterile
FHC, INC.
MTDPZN(AO)(AO1)-00650
In Commercial Distribution

  • 10873263006501 ()
  • 00873263006504 ()

  • Outer Diameter: 1.27 Millimeter
  • Impedance: Megaohms
  • Length: 274 Millimeter
  • Length: 282 Millimeter
  • Length: 3 Millimeter
MTDPZN(AO)(AO1)

  • Depth electrode
microTargeting(TM) Electrode, Differential, Tungsten, Nonsterile
FHC, INC.
MTDWXN(BS)(OC5)-00646
In Commercial Distribution

  • 10873263006464 ()
  • 00873263006467 ()

  • Length: 1 Millimeter
  • Outer Diameter: 0.55 Millimeter
  • Length: 235 Millimeter
  • Length: 229 Millimeter
MTDWXN(BS)(OC5)

  • Depth electrode
microTargeting(TM) Electrode, differential, Platinum/Iridium, nonsterile
FHC, INC.
MTDPZN(PA)(MP1)-00641
In Commercial Distribution

  • 10873263006419 ()
  • 00873263006412 ()

  • Outer Diameter: 0.5 Millimeter
  • Impedance: Megaohms
  • Length: 10 Millimeter
  • Length: 220.72 Millimeter
  • Length: 215.72 Millimeter
MTDPZN(PA)(MP1)

  • Depth electrode
microTargeting(TM) Electrode, differential, Platinum/Iridium, nonsterile
FHC, INC.
MTDPLN(PA)(MP1)-00639
In Commercial Distribution

  • 10873263006396 ()
  • 00873263006399 ()

  • Impedance: Megaohms
  • Length: 215.72 Millimeter
  • Length: 10 Millimeter
  • Outer Diameter: 0.5 Millimeter
  • Length: 220.72 Millimeter
MTDPLN(PA)(MP1)

  • Depth electrode
microTargeting(TM) Electrode, differential, Platinum/Iridium, nonsterile
FHC, INC.
MTDPBN(PS)(PS1)-00632
In Commercial Distribution

  • 10873263006327 ()
  • 00873263006320 ()

  • Length: 271.4 Millimeter
  • Length: 256.4 Millimeter
  • Impedance: Megaohms
  • Length: 10 Millimeter
  • Outer Diameter: 0.86 Millimeter
MTDPBN(PS)(PS1)

  • Depth electrode
microTargeting(TM) Electrode, differential, tungsten, nonsterile
FHC, INC.
MTDWBN(BP)(BP8)-00582
In Commercial Distribution

  • 10873263005825 ()
  • 00873263005828 ()

  • Length: 3 Millimeter
  • Outer Diameter: 0.77 Millimeter
  • Length: 271.4 Millimeter
  • Length: 263.4 Millimeter
  • Impedance: Megaohms
MTDWBN(BP)(BP8)

  • Depth electrode
microTargeting(TM) Electrode, 6x, non-sterile, D.ZAP(Z), for use with Nexframe(R) and STar Drive
FHC, INC.
5735Z-00581
In Commercial Distribution

  • 10873263005818 ()
  • 00873263005811 ()

  • Outer Diameter: 0.56 Millimeter
  • Length: 242.2 Millimeter
  • Length: 227.2 Millimeter
  • Impedance: Megaohms
  • Length: 10 Millimeter
5735Z

  • Depth electrode
microTargeting(TM) Electrode, 6x, non-sterile, D.ZAP(L), for use with Nexframe(R) and STar Drive
FHC, INC.
5735L-00580
In Commercial Distribution

  • 10873263005801 ()
  • 00873263005804 ()

  • Length: 242.2 Millimeter
  • Outer Diameter: 0.56 Millimeter
  • Length: 227.2 Millimeter
  • Length: 10 Millimeter
  • Impedance: Megaohms
5735L

  • Depth electrode
microTargeting(TM) Electrode, 6x, non-sterile, for use with Nexframe(R) and STar Drive
FHC, INC.
5730R-00579
In Commercial Distribution

  • 10873263005795 ()
  • 00873263005798 ()

  • Outer Diameter: 0.56 Millimeter
  • Impedance: Megaohms
  • Length: 10 Millimeter
  • Length: 242.2 Millimeter
  • Length: 227.2 Millimeter
5730R

  • Depth electrode
microTargeting(TM) Electrode, non-sterile, DZAP(Z), for use with Nexframe(R)
FHC, INC.
5035Z-00577
In Commercial Distribution

  • 10873263005771 ()
  • 00873263005774 ()

  • Length: 10 Millimeter
  • Length: 249.2 Millimeter
  • Length: 234.2 Millimeter
  • Impedance: Megaohms
  • Outer Diameter: 0.56 Millimeter
5035Z

  • Depth electrode
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