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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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Provox Vega XtraSeal 20Fr 4mm - 07331791010989

Provox Vega voice prosthesis is an indwelling, low resistance voice prosthesis intended for voice restoration after surgical removal of the larynx. The Provox Insertion System is a single-use replacement device intended for anterograde insertion only. Provox Vega XtraSeal has an additional enlarged esophageal flange that is intended to solve problems with leakage around the voice prosthesis
Atos Medical AB
8294
In Commercial Distribution

  • 07331791010989 ()

  • Length: 4 Millimeter
  • Diameter Outer - Fr 20
8294

  • Tracheoesophageal speech valve, indwelling

Provox Vega 20Fr 15mm - 07331791010859

Provox Vega voice prosthesis is an indwelling, low resistance voice prosthesis intended for voice restoration after surgical removal of the larynx. The Provox Insertion System is a single-use replacement device intended for anterograde insertion only.
Atos Medical AB
8281
In Commercial Distribution

  • 07331791010859 ()

  • Length: 15 Millimeter
  • Diameter Outer - Fr 20
8281

  • Tracheoesophageal speech valve, indwelling

Provox Vega 20Fr 12.5mm - 07331791010842

Provox Vega voice prosthesis is an indwelling, low resistance voice prosthesis intended for voice restoration after surgical removal of the larynx. The Provox Insertion System is a single-use replacement device intended for anterograde insertion only.
Atos Medical AB
8280
In Commercial Distribution

  • 07331791010842 ()

  • Length: 12.5 Millimeter
  • Diameter Outer - Fr 20
8280

  • Tracheoesophageal speech valve, indwelling

Provox Vega 20Fr 10mm - 07331791010835

Provox Vega voice prosthesis is an indwelling, low resistance voice prosthesis intended for voice restoration after surgical removal of the larynx. The Provox Insertion System is a single-use replacement device intended for anterograde insertion only.
Atos Medical AB
8279
In Commercial Distribution

  • 07331791010835 ()

  • Length: 10 Millimeter
  • Diameter Outer - Fr 20
8279

  • Tracheoesophageal speech valve, indwelling

Provox Vega 20Fr 8mm - 07331791010828

Provox Vega voice prosthesis is an indwelling, low resistance voice prosthesis intended for voice restoration after surgical removal of the larynx. The Provox Insertion System is a single-use replacement device intended for anterograde insertion only.
Atos Medical AB
8278
In Commercial Distribution

  • 07331791010828 ()

  • Length: 8 Millimeter
  • Diameter Outer - Fr 20
8278

  • Tracheoesophageal speech valve, indwelling

Provox Vega 20Fr 6mm - 07331791010811

Provox Vega voice prosthesis is an indwelling, low resistance voice prosthesis intended for voice restoration after surgical removal of the larynx. The Provox Insertion System is a single-use replacement device intended for anterograde insertion only.
Atos Medical AB
8277
In Commercial Distribution

  • 07331791010811 ()

  • Length: 6 Millimeter
  • Diameter Outer - Fr 20
8277

  • Tracheoesophageal speech valve, indwelling

Provox Vega 20Fr 4mm - 07331791010804

Provox Vega voice prosthesis is an indwelling, low resistance voice prosthesis intended for voice restoration after surgical removal of the larynx. The Provox Insertion System is a single-use replacement device intended for anterograde insertion only.
Atos Medical AB
8276
In Commercial Distribution

  • 07331791010804 ()

  • Length: 4 Millimeter
  • Diameter Outer - Fr 20
8276

  • Tracheoesophageal speech valve, indwelling

Provox Vega Puncture Set 20Fr 12.5mm - 07331791009143

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
8146US
In Commercial Distribution

  • 07331791009143 ()

  • Length: 12.5 Millimeter
  • Diameter Outer - Fr 20
8146US

  • Tracheoesophageal speech valve, indwelling

Provox Vega Puncture Set 20Fr 10mm - 07331791009136

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

Provox Vega Puncture Set 20Fr 8mm - 07331791009129

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
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