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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SIGNATURE ORTHOPAEDICS PTY LTD
111-39-2002
In Commercial Distribution

  • 09348215080112 ()


  • Surgical implant template, reusable
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 a minimum of 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
N/A
In Commercial Distribution

  • W41020AU201S1969 ()

  • Area/Surface Area: 50 Square centimeter


  • Cultured skin autograft/xenograft
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
Pediatiric harness for gait training.
M.A.S.S. Rehab, LLC
Standard
In Commercial Distribution

  • G505MRPH0 ()


  • Gait rehabilitation system harness
Simple two-loop spotting harness for gait and balance training.
M.A.S.S. Rehab, LLC
Standard
In Commercial Distribution

  • G505MRMS0 ()


  • Gait rehabilitation system harness
Harness for Healing Solutions Robotic Trainer
M.A.S.S. Rehab, LLC
Standard
In Commercial Distribution

  • G505MRHSH0 ()


  • Gait rehabilitation system harness
Balance harness for balance training activities
M.A.S.S. Rehab, LLC
Standard
In Commercial Distribution

  • G505MRBHS0 ()


  • Gait rehabilitation system harness
Gait Belt, Heavy Duty
DEROYAL INDUSTRIES, INC.
M2616D72
In Commercial Distribution

  • 50749756242412 ()
  • 00749756242417 ()
M2616D72

  • Gait rehabilitation system harness
Gait Belt, Heavy Duty
DEROYAL INDUSTRIES, INC.
M2616D01
In Commercial Distribution

  • 00749756232609 ()
M2616D01

  • Gait rehabilitation system harness
Gait Belt, Heavy Duty
DEROYAL INDUSTRIES, INC.
M5167
In Commercial Distribution

  • 00749756113076 ()
M5167

  • Gait rehabilitation system harness
Gait Belt, Heavy Duty
DEROYAL INDUSTRIES, INC.
M5166-72
In Commercial Distribution

  • 50749756113064 ()
  • 00749756113069 ()
M5166-72

  • Gait rehabilitation system harness
Gait Belt, Heavy Duty
DEROYAL INDUSTRIES, INC.
M5166
In Commercial Distribution

  • 50749756113057 ()
  • 00749756113052 ()
M5166

  • Gait rehabilitation system harness
Bariatric Heavy Duty Gait Belt
DEROYAL INDUSTRIES, INC.
M5166-84
In Commercial Distribution

  • 00749756367769 ()
M5166-84

  • Gait rehabilitation system harness
Gait Belt, Heavy Duty
DEROYAL INDUSTRIES, INC.
M5167-B
In Commercial Distribution

  • 50749756352838 ()
  • 00749756352833 ()
M5167-B

  • Gait rehabilitation system harness
Gait Belt, Heavy Duty
DEROYAL INDUSTRIES, INC.
M2616D25
In Commercial Distribution

  • 50749756281930 ()
  • 00749756281935 ()
M2616D25

  • Gait rehabilitation system harness
Gait rehabilitation system harness
Liko AB
3666006
In Commercial Distribution

  • 00887761984110 ()


  • Gait rehabilitation system harness
Gait rehabilitation system harness
Liko AB
3666005
In Commercial Distribution

  • 00887761984103 ()


  • Gait rehabilitation system harness
Gait rehabilitation system harness
Liko AB
3666004
In Commercial Distribution

  • 00887761984097 ()


  • Gait rehabilitation system harness
Gait rehabilitation system harness
Liko AB
3564118
In Commercial Distribution

  • 00887761983847 ()


  • Gait rehabilitation system harness
Gait rehabilitation system harness
Liko AB
3564117
In Commercial Distribution

  • 00887761983830 ()


  • Gait rehabilitation system harness
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