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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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Alpha-Tec Systems - 00816085023786

Triton X-100 20%
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085023786 ()
X000401

  • Faecal parasite specimen concentration kit IVD

Alpha-Tec Systems - 00816085023779

PRS Parasite Recovery System (Funnel, Triton X, 15 mL Centrifuge Tube, Cap)
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085023779 ()
0004045

  • Faecal parasite specimen concentration kit IVD

Epicel (cultured epidermal autografts) - W41020AU201P0001

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

Luxisse - 00817724029039

Yttria Stabilized Zirconia
HEANY INDUSTRIES, INC.
0
In Commercial Distribution

  • 00817724029039 ()

  • Height: 30 Millimeter
  • Length: 98 Millimeter
MDDK3702ZF30B1

  • Dental appliance fabrication material, ceramic

Luxisse - 00817724029022

Yttira Stabilized Zirconia
HEANY INDUSTRIES, INC.
0
In Commercial Distribution

  • 00817724029022 ()
MDDK3701ZF10B2

  • Dental appliance fabrication material, ceramic

LUXISSE - 00817724028988

YTTRIA STABILIZED ZIRCONIA
HEANY INDUSTRIES, INC.
0
In Commercial Distribution

  • 00817724028988 ()

  • Outer Diameter: 98 Millimeter
  • Height: 10 Millimeter
MDDK3701ZF10D4

  • Dental appliance fabrication material, ceramic

LUXISSE - 00817724028971

YTTRIA STABILIZED ZIRCONIA
HEANY INDUSTRIES, INC.
0
In Commercial Distribution

  • 00817724028971 ()

  • Outer Diameter: 98 Millimeter
  • Height: 10 Millimeter
MDDK3701ZF10C4

  • Dental appliance fabrication material, ceramic

LUXISSE - 00817724028964

YTTRIA STABILIZED ZIRCONIA
HEANY INDUSTRIES, INC.
0
In Commercial Distribution

  • 00817724028964 ()

  • Outer Diameter: 98 Millimeter
  • Height: 10 Millimeter
MDDK3701ZF10C3

  • Dental appliance fabrication material, ceramic

LUXISSE - 00817724028957

YTTRIA STABILIZED ZIRCONIA
HEANY INDUSTRIES, INC.
0
In Commercial Distribution

  • 00817724028957 ()

  • Outer Diameter: 98 Millimeter
  • Height: 10 Millimeter
MDDK3701ZF10C1

  • Dental appliance fabrication material, ceramic

LUXISSE - 00817724028940

YTTRIA STABILIZED ZIRCONIA
HEANY INDUSTRIES, INC.
0
In Commercial Distribution

  • 00817724028940 ()

  • Outer Diameter: 98 Millimeter
  • Height: 10 Millimeter
MDDK3701ZF10A4

  • Dental appliance fabrication material, ceramic
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