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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DELIV SYS ENS1022 ENSEMBLE II US
MEDTRONIC, INC.
ENS1022
In Commercial Distribution

  • 00643169713901 ()

  • Outer Balloon Size 22 mm


  • Pulmonary transcatheter heart valve bioprosthesis
DELIV SYS ENS1020 ENSEMBLE II US
MEDTRONIC, INC.
ENS1020
In Commercial Distribution

  • 00643169713895 ()

  • Outer Balloon Size 20 mm


  • Pulmonary transcatheter heart valve bioprosthesis
DELIV SYS ENS1018 ENSEMBLE II US
MEDTRONIC, INC.
ENS1018
In Commercial Distribution

  • 00643169713888 ()

  • Outer Balloon Size 18 mm


  • Pulmonary transcatheter heart valve bioprosthesis
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
Not in Commercial Distribution

  • 24993478020239 ()
  • 14993478020232 ()
  • 04993478010045 ()
N/A

  • Haemoperfusion system absorption column
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-25
Not in Commercial Distribution

  • 24993478020222 ()
  • 14993478020225 ()
  • 04993478010069 ()
N/A

  • Haemoperfusion system absorption column
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-15
Not in Commercial Distribution

  • 14993478020218 ()
  • 04993478010052 ()
  • 24993478020215 ()
N/A

  • Haemoperfusion system absorption column
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-25
In Commercial Distribution

  • 04993478010069 ()
  • 14993478010066 ()
  • 24993478010063 ()
N/A

  • Haemoperfusion system absorption column
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-15
In Commercial Distribution

  • 04993478010052 ()
  • 14993478010059 ()
  • 24993478010056 ()
N/A

  • Haemoperfusion system absorption column
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
Stent
MICROVENTION INC.
214049-LVIS-C
In Commercial Distribution

  • 00810170019043 ()

  • 5.5 mm x 34 mm
214049-LVIS

  • Bare-metal intracranial vascular stent
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