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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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LIXELLE - 14993478010042

The Lixelle(r) beta 2-microglobulin apheresis column is indicated for the treatment of patients with clinically-diagnosed dialysis-related amyloidosis (DRA).
KANEKA CORPORATION
S-35
In Commercial Distribution

  • 24993478010049 ()
  • 14993478010042 ()
  • 04993478010045 ()
N/A

  • Haemoperfusion system absorption column

Epicel (cultured epidermal autografts) - W41020AU201S1969

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

restor3d Total Talus Replacement - 00840097509907

Impactor, Contoured
Restor3d, Inc.
6102-610
In Commercial Distribution

  • 00840097509907 ()


  • Custom-made hand/foot bone prosthesis

restor3d Total Talus Replacement - 00840097509891

Impactor, Flat
Restor3d, Inc.
6102-600
In Commercial Distribution

  • 00840097509891 ()


  • Custom-made hand/foot bone prosthesis

restor3d Total Talus Replacement - 00840097509884

Trial, Total Talus, 110%
Restor3d, Inc.
6102-205
In Commercial Distribution

  • 00840097509884 ()


  • Custom-made hand/foot bone prosthesis

restor3d Total Talus Replacement - 00840097509877

Trial, Total Talus, 105%
Restor3d, Inc.
6102-204
In Commercial Distribution

  • 00840097509877 ()


  • Custom-made hand/foot bone prosthesis

restor3d Total Talus Replacement - 00840097509860

Trial, Total Talus, 100%
Restor3d, Inc.
6102-203
In Commercial Distribution

  • 00840097509860 ()


  • Custom-made hand/foot bone prosthesis

restor3d Total Talus Replacement - 00840097509853

Trial, Total Talus, 95%
Restor3d, Inc.
6102-202
In Commercial Distribution

  • 00840097509853 ()


  • Custom-made hand/foot bone prosthesis

restor3d Total Talus Replacement - 00840097509846

Trial, Total Talus, 90%
Restor3d, Inc.
6102-201
In Commercial Distribution

  • 00840097509846 ()


  • Custom-made hand/foot bone prosthesis

restor3d Total Talus Replacement - 00840097509839

Total Talus, With Suture Hole, 110%
Restor3d, Inc.
1102-15
In Commercial Distribution

  • 00840097509839 ()


  • Custom-made hand/foot bone prosthesis
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