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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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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
PUMP 8637-20 SYNCHMED II 20ML PF
MEDTRONIC, INC.
8637-20
In Commercial Distribution

  • 00643169100831 ()

  • Total Volume: 20.0 Milliliter


  • Implantable intrathecal infusion pump, programmable
PUMP 8637-40 SYNCHMED II 40ML PF
MEDTRONIC, INC.
8637-40
In Commercial Distribution

  • 00643169100824 ()

  • Total Volume: 40.0 Milliliter


  • Implantable intrathecal infusion pump, programmable
MICROWIRE DEPTHALON ELECTRODE, 7 X 2MM MACRO CONTACTS, 9 X 75UM MICROWIRE CONTACTS, 30MM RECORDING LENGTH, 0.8MM DIA., MINI CONNECTOR
PMT CORPORATION
2104-07-09-001
In Commercial Distribution

  • 00650551001799 ()


  • Depth electrode
SEEG, 16 CONTACT, 4-2MM & 12-0.5MM CONTACT, NON-STANDARD SPACNG AND 37MM BETWEEN CONTACT 9&10 WITH 9-2MM BLANK CONTACTS, 57MM RECORDING DEPTH, MINI CONNECTOR, REMOVABLE STYLET, 2.4MM DRILL
PMT CORPORATION
2102-16-183
In Commercial Distribution

  • 00650551001430 ()


  • Depth electrode
SEEG, 16 CONTACT, 4-2MM & 12-0.5MM CONTACT, NON-STANDARD SPACING AND 33MM BETWEEN CONTACT 9&10 WITH 9-2MM BLANK CONTACTS, 53MM RECORDING DEPTH, MINI CONNECTOR, REMOVABLE STYLET, 2.4MM DRILL
PMT CORPORATION
2102-16-182
In Commercial Distribution

  • 00650551001423 ()


  • Depth electrode
SEEG, 16 CONTACT, 4-2MM & 12-0.5MM CONTACT, NON-STANDARD SPACING AND 29MM BETWEEN CONTACT 9&10 WITH 7-2MM BLANK CONTACTS, 49MM RECORDING DEPTH, MINI CONNECTOR, REMOVABLE STYLET, 2.4MM DRILL
PMT CORPORATION
2102-16-181
In Commercial Distribution

  • 00650551001416 ()


  • Depth electrode
SEEG, 16 CONTACT, 4-2MM & 12-0.5MM CONTACT, NON-STANDARD SPACING AND 25MM BETWEEN CONTACT 9&10 WITH 6-2MM BLANK CONTACTS, 45MM RECORDING DEPTH, MINI CONNECTOR, REMOVABLE STYLET, 2.4MM DRILL
PMT CORPORATION
2102-16-180
In Commercial Distribution

  • 00650551001409 ()


  • Depth electrode
SEEG, 16 CONTACT, 6-2MM & 10-0.5MM CONTACT, NON-STANDARD SPACING AND 33MM BETWEEN CONTACT 9&10 WITH 8-2MM BLANK CONTACTS, 66MM RECORDING DEPTH, MINI CONNECTOR, REMOVABLE STYLET, 2.4MM DRILL
PMT CORPORATION
2102-16-179
In Commercial Distribution

  • 00650551001393 ()


  • Depth electrode
SEEG, 16 CONTACT, 6-2MM & 10-0.5MM CONTACT, NON-STANDARD SPACING AND 27MM BETWEEN CONTACT 9&10 WITH 6-2MM BLANK CONTACTS, 60MM RECORDING DEPTH, MINI CONNECTOR, REMOVABLE STYLET, 2.4MM DRILL
PMT CORPORATION
2102-16-178
In Commercial Distribution

  • 00650551001386 ()


  • Depth electrode
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