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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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Indications for FH: The LIPOSORBER® LA-15 System is indicated for use in performing low density lipoprotein cholesterol (LDL-C) apheresis to acutely remove LDL-C from the plasma. Indications for FSGS: The LIPOSORBER® LA-15 System is indicated for use in the treatment of adult and pediatric patients with nephrotic syndrome associated with primary focal segmental glomerulosclerosis (FSGS).
KANEKA CORPORATION
LA-15
In Commercial Distribution

  • 24993478010117 ()
  • 14993478010110 ()
  • 04993478010113 ()
N/A

  • Haemoperfusion system absorption column
No Description
TORAY INDUSTRIES,INC.
PTMC-30
In Commercial Distribution

  • 14960685200054 ()

  • Balloon Diameter Range: 26-30 Millimeter
  • Catheter Gauge: 12 French
  • Length: 70 Centimeter


  • Cardiac valvuloplasty catheter
No Description
TORAY INDUSTRIES,INC.
PTMC-28
In Commercial Distribution

  • 14960685200047 ()

  • Balloon Diameter Range: 24-28 Millimeter
  • Catheter Gauge: 12 French
  • Length: 70 Centimeter


  • Cardiac valvuloplasty catheter
No Description
TORAY INDUSTRIES,INC.
PTMC-26
In Commercial Distribution

  • 14960685200030 ()

  • Balloon Diameter Range: 22-26 Millimeter
  • Catheter Gauge: 12 French
  • Length: 70 Centimeter


  • Cardiac valvuloplasty catheter
No Description
Biomet Orthopedics, LLC
010002749
In Commercial Distribution

  • 00880304926912 ()

  • 3.5MM
010002749

  • Surgical screwdriver, reusable
No Description
Biomet Orthopedics, LLC
110003456
In Commercial Distribution

  • 00880304926905 ()
110003456

  • Orthopaedic implant aiming/guiding block, reusable
No Description
Biomet Orthopedics, LLC
010002726
In Commercial Distribution

  • 00880304926868 ()
010002726

  • Orthopaedic implant impactor, reusable
No Description
Biomet Orthopedics, LLC
010002723
In Commercial Distribution

  • 00880304926851 ()
010002723

  • Orthopaedic implant-instrument extension adaptor, reusable
No Description
Biomet Orthopedics, LLC
010002725
In Commercial Distribution

  • 00880304926844 ()
010002725

  • Orthopaedic implant impactor, reusable
No Description
Biomet Orthopedics, LLC
010002748
In Commercial Distribution

  • 00880304926837 ()

  • 3.5MM
010002748

  • Surgical screwdriver, reusable
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