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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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Nocardia Stain Control Slides
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085020167 ()
0003248S

  • Biological stain control IVD
CELL-BOND Slide, 1 Red well, no background
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085020105 ()
S003223

  • General specimen microscopy slide IVD, single-use
CELL-BOND Slides, 2 wells [15mm], red background
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085020075 ()
S003222

  • General specimen microscopy slide IVD, single-use
Methanol, Absolute
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085024134 ()
0003339

  • Biological stain IVD
VTM Viral Transport Medium Pack
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085024127 ()
0003730

  • Sputum specimen liquefaction/decontamination kit IVD
QC1 Malaria Slide
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085024103 ()
  • 00816085024110 ()
0003267

  • Biological stain control IVD
NALC Diluent
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085024097 ()
0004820

  • Sputum specimen liquefaction/decontamination kit IVD
NALC Diluent
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085024080 ()
X000489

  • Sputum specimen liquefaction/decontamination kit IVD
NAC-PAC EA3 (3.0%) w/ NALC powder
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085024059 ()
  • 00816085024073 ()
0004813

  • Sputum specimen liquefaction/decontamination kit IVD
NAC-PAC EA3 (2.5%) w/ NALC powder
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085024042 ()
  • 00816085024066 ()
0004819

  • Sputum specimen liquefaction/decontamination kit IVD
NAC-PAC EA3 (3.0%) tray w/ NALC powder
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085024059 ()


  • Sputum specimen liquefaction/decontamination kit IVD
NAC-PAC EA3 (2.5%) tray w/ NALC powder
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085024042 ()


  • Sputum specimen liquefaction/decontamination kit IVD
0.9% Saline 4.0ml
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085024035 ()
0003516

  • Sputum specimen liquefaction/decontamination kit IVD
0.9% Saline 4.5ml
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085024028 ()
0003520

  • Sputum specimen liquefaction/decontamination kit IVD
0.9% Saline 5.0ml
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085024011 ()
0003521

  • Sputum specimen liquefaction/decontamination kit IVD
Bovine Albumin Fraction V 10x10ml
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085023861 ()
0003470

  • Sputum specimen liquefaction/decontamination kit IVD
Centrifuge Tubes, 50 mL, 20 Bags x 25 Tubes
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085023847 ()
0001352

  • Faecal parasite specimen concentration kit IVD
Centrifuge Tubes, 15 mL, 20 Bags x 25 Tubes
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085023830 ()
0001518

  • Faecal parasite specimen concentration kit IVD
Centrifuge Tubes, 15 mL, 20 Trays x 25 Tubes
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085023823 ()
0001516

  • Faecal parasite specimen concentration kit IVD
Centrifuge Tubes, 50 mL, 20 Bags x 25 Tubes
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085023809 ()
0001350

  • Faecal parasite specimen concentration kit IVD
Triton X-100 20%
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085023793 ()
0003358

  • Faecal parasite specimen concentration kit IVD
Triton X-100 20%
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085023786 ()
X000401

  • Faecal parasite specimen concentration kit IVD
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) 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
Yttria Stabilized Zirconia
HEANY INDUSTRIES, INC.
0
In Commercial Distribution

  • 00817724029039 ()

  • Height: 30 Millimeter
  • Length: 98 Millimeter
MDDK3702ZF30B1

  • Dental appliance fabrication material, ceramic
Yttira Stabilized Zirconia
HEANY INDUSTRIES, INC.
0
In Commercial Distribution

  • 00817724029022 ()
MDDK3701ZF10B2

  • Dental appliance fabrication material, ceramic
YTTRIA STABILIZED ZIRCONIA
HEANY INDUSTRIES, INC.
0
In Commercial Distribution

  • 00817724028988 ()

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

  • Dental appliance fabrication material, ceramic
YTTRIA STABILIZED ZIRCONIA
HEANY INDUSTRIES, INC.
0
In Commercial Distribution

  • 00817724028971 ()

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

  • Dental appliance fabrication material, ceramic
YTTRIA STABILIZED ZIRCONIA
HEANY INDUSTRIES, INC.
0
In Commercial Distribution

  • 00817724028964 ()

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

  • Dental appliance fabrication material, ceramic
YTTRIA STABILIZED ZIRCONIA
HEANY INDUSTRIES, INC.
0
In Commercial Distribution

  • 00817724028957 ()

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

  • Dental appliance fabrication material, ceramic
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