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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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The Provox Vega Puncture Set is a device for creating a primary or secondary TE puncture, with subsequent dilatation of that puncture to a width that facilitates placement of the included Provox Vega voice prosthesis. The Provox Vega voice prosthesis is preloaded on the Puncture Dilator, which is part of the device. The Provox Vega Puncture Set is intended for single use only.
Atos Medical AB
8145US
In Commercial Distribution

  • 07331791009136 ()

  • Length: 10 Millimeter
  • Diameter Outer - Fr 20
8145US

  • Tracheoesophageal speech valve, indwelling
The Provox Vega Puncture Set is a device for creating a primary or secondary TE puncture, with subsequent dilatation of that puncture to a width that facilitates placement of the included Provox Vega voice prosthesis. The Provox Vega voice prosthesis is preloaded on the Puncture Dilator, which is part of the device. The Provox Vega Puncture Set is intended for single use only.
Atos Medical AB
8144US
In Commercial Distribution

  • 07331791009129 ()

  • Length: 8 Millimeter
  • Diameter Outer - Fr 20
8144US

  • Tracheoesophageal speech valve, indwelling
The Provox Vega Puncture Set is a device for creating a primary or secondary TE puncture, with subsequent dilatation of that puncture to a width that facilitates placement of the included Provox Vega voice prosthesis. The Provox Vega voice prosthesis is preloaded on the Puncture Dilator, which is part of the device. The Provox Vega Puncture Set is intended for single use only.
Atos Medical AB
8143US
In Commercial Distribution

  • 07331791009112 ()

  • Length: 15 Millimeter
  • Diameter Outer - Fr 17
8143US

  • Tracheoesophageal speech valve, indwelling
The Provox Vega Puncture Set is a device for creating a primary or secondary TE puncture, with subsequent dilatation of that puncture to a width that facilitates placement of the included Provox Vega voice prosthesis. The Provox Vega voice prosthesis is preloaded on the Puncture Dilator, which is part of the device. The Provox Vega Puncture Set is intended for single use only.
Atos Medical AB
8142US
In Commercial Distribution

  • 07331791009105 ()

  • Length: 12.5 Millimeter
  • Diameter Outer - Fr 17
8142US

  • Tracheoesophageal speech valve, indwelling
The Provox Vega Puncture Set is a device for creating a primary or secondary TE puncture, with subsequent dilatation of that puncture to a width that facilitates placement of the included Provox Vega voice prosthesis. The Provox Vega voice prosthesis is preloaded on the Puncture Dilator, which is part of the device. The Provox Vega Puncture Set is intended for single use only.
Atos Medical AB
8141US
In Commercial Distribution

  • 07331791009099 ()

  • Length: 10 Millimeter
  • Diameter Outer - Fr 17
8141US

  • Tracheoesophageal speech valve, indwelling
The Provox Vega Puncture Set is a device for creating a primary or secondary TE puncture, with subsequent dilatation of that puncture to a width that facilitates placement of the included Provox Vega voice prosthesis. The Provox Vega voice prosthesis is preloaded on the Puncture Dilator, which is part of the device. The Provox Vega Puncture Set is intended for single use only.
Atos Medical AB
8140US
In Commercial Distribution

  • 07331791009082 ()

  • Length: 8 Millimeter
  • Diameter Outer - Fr 17
8140US

  • Tracheoesophageal speech valve, indwelling
The Ovation iX™ Iliac Extensions are components of the Ovation Prime, Ovation iX, and Alto™ Abdominal Stent Graft Systems. The Ovation iX™ Iliac Extensions are comprised of a nitinol stent encapsulated in low-permeability PTFE. Iliac extensions may be used to extend the length of the device, where indicated.
Endologix, Inc.
TV-EX282845-J
In Commercial Distribution

  • 00850007370077 ()

  • Stent Diameter: 28 Millimeter
  • Catheter Working Length: 60 Millimeter
  • Outer Diameter: 15 Femtometer
  • Lumen/Inner Diameter: 13 Femtometer
  • Stent Length: 45 Millimeter
TV-EX282845-J

  • Abdominal aorta endovascular stent-graft
The Ovation iX™ Iliac Extensions are components of the Ovation Prime, Ovation iX, and Alto™ Abdominal Stent Graft Systems. The Ovation iX™ Iliac Extensions are comprised of a nitinol stent encapsulated in low-permeability PTFE. Iliac extensions may be used to extend the length of the device, where indicated.
Endologix, Inc.
TV-EX222245-J
In Commercial Distribution

  • 00850007370060 ()

  • Stent Diameter: 22 Millimeter
  • Catheter Working Length: 60 Centimeter
  • Outer Diameter: 14 Femtometer
  • Lumen/Inner Diameter: 12 Femtometer
  • Stent Length: 45 Millimeter
TV-EX222245-J

  • Abdominal aorta endovascular stent-graft
The Ovation iX™ Iliac Extensions are components of the Ovation Prime, Ovation iX, and Alto™ Abdominal Stent Graft Systems. The Ovation iX™ Iliac Extensions are comprised of a nitinol stent encapsulated in low-permeability PTFE. Iliac extensions may be used to extend the length of the device, where indicated.
Endologix, Inc.
TV-EX181845-J
In Commercial Distribution

  • 00850007370053 ()

  • Stent Diameter: 18 Millimeter
  • Catheter Working Length: 60 Centimeter
  • Outer Diameter: 13 Femtometer
  • Lumen/Inner Diameter: 11 Femtometer
  • Stent Length: 45 Millimeter
TV-EX181845-J

  • Abdominal aorta endovascular stent-graft
The Ovation iX™ Iliac Extensions are components of the Ovation Prime, Ovation iX, and Alto™ Abdominal Stent Graft Systems. The Ovation iX™ Iliac Extensions are comprised of a nitinol stent encapsulated in low-permeability PTFE. Iliac extensions may be used to extend the length of the device, where indicated.
Endologix, Inc.
TV-EX161645-J
In Commercial Distribution

  • 00850007370046 ()

  • Stent Length: 16 Millimeter
  • Catheter Working Length: 60 Centimeter
  • Outer Diameter: 13 Femtometer
  • Lumen/Inner Diameter: 11 Femtometer
  • Stent Length: 45 Millimeter
TV-EX161645-J

  • Abdominal aorta endovascular stent-graft
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