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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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Endovascular Stent-Graft System
Bolton Medical Inc.
28-L2-11-080U
In Commercial Distribution

  • 00843576151987 ()

  • Outer Diameter: 15 Millimeter
  • Outer Diameter: 11 Millimeter
  • Length: 81 Millimeter
  • Catheter Gauge: 13 French
28-L2-11-080U

  • Abdominal aorta endovascular stent-graft
Endovascular Stent-Graft System
Bolton Medical Inc.
28-S2-13-080U
In Commercial Distribution

  • 00843576151963 ()

  • Outer Diameter: 13 Millimeter
  • Length: 79 Millimeter
  • Catheter Gauge: 13 French
28-S2-13-080U

  • Abdominal aorta endovascular stent-graft
Endovascular Stent-Graft System
Bolton Medical Inc.
28-S2-09-080U
In Commercial Distribution

  • 00843576151949 ()

  • Outer Diameter: 9 Millimeter
  • Length: 79 Millimeter
  • Catheter Gauge: 13 French
28-S2-09-080U

  • Abdominal aorta endovascular stent-graft
Indications for FH: The SULFLUX KP-05 Plasma Separator is one of three disposable device components of the LIPOSORBER® LA-15 System. 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 SULFLUX KP-05 Plasma Separator is one of three disposable device components of the LIPOSORBER® LA-15 System. 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 PHARMA AMERICA LLC
KP-05
In Commercial Distribution

  • 14537693900636 ()
  • 04537693900639 ()


  • Apheresis system filter, whole blood
No Description
Arcera GmbH
N/A
In Commercial Distribution

  • 04260648380049 ()


  • Synovial fluid supplementation medium
Endovascular Stent-Graft System
Bolton Medical Inc.
28-C2-36-070U
In Commercial Distribution

  • 00843576152793 ()

  • Outer Diameter: 36 Millimeter
  • Length: 70 Millimeter
  • Catheter Gauge: 19 French
28-C2-36-070U

  • Abdominal aorta endovascular stent-graft
Endovascular Stent-Graft System
Bolton Medical Inc.
28-C2-33-070U
In Commercial Distribution

  • 00843576152786 ()

  • Outer Diameter: 33 Millimeter
  • Length: 70 Millimeter
  • Catheter Gauge: 19 French
28-C2-33-070U

  • Abdominal aorta endovascular stent-graft
Endovascular Stent-Graft System
Bolton Medical Inc.
28-C2-28-070U
In Commercial Distribution

  • 00843576152762 ()

  • Outer Diameter: 28 Millimeter
  • Length: 70 Millimeter
  • Catheter Gauge: 18 French
28-C2-28-070U

  • Abdominal aorta endovascular stent-graft
Endovascular Stent-Graft System
Bolton Medical Inc.
28-C2-26-070U
In Commercial Distribution

  • 00843576152755 ()

  • Outer Diameter: 26 Millimeter
  • Length: 70 Millimeter
  • Catheter Gauge: 18 French
28-C2-26-070U

  • Abdominal aorta endovascular stent-graft
Endovascular Stent-Graft System
Bolton Medical Inc.
28-C2-22-070U
In Commercial Distribution

  • 00843576152731 ()

  • Outer Diameter: 22 Millimeter
  • Length: 70 Millimeter
  • Catheter Gauge: 18 French
28-C2-22-070U

  • Abdominal aorta endovascular stent-graft
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