Company Name Brand Name GMDN Term FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size 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
No Description
Synapse Biomedical, Inc.
20-0074
In Commercial Distribution

  • 00852184003618 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system
No Description
Synapse Biomedical, Inc.
21-0039-99
In Commercial Distribution

  • 00852184003588 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system
No Description
Synapse Biomedical, Inc.
23-0010
In Commercial Distribution

  • 00852184003496 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system
No Description
Synapse Biomedical, Inc.
22-0034
In Commercial Distribution

  • 00852184003465 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system
No Description
Synapse Biomedical, Inc.
22-0030
In Commercial Distribution

  • 00852184003434 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system
No Description
Synapse Biomedical, Inc.
22-0028
In Commercial Distribution

  • 00852184003410 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system
No Description
Synapse Biomedical, Inc.
22-0022
In Commercial Distribution

  • 00852184003403 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system
No Description
Synapse Biomedical, Inc.
22-0021
In Commercial Distribution

  • 00852184003397 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system
No Description
Synapse Biomedical, Inc.
22-0020
In Commercial Distribution

  • 00852184003380 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system
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