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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 voice prosthesis is an indwelling, low resistance voice prosthesis intended for voice restoration after surgical removal of the larynx. The prosthesis comes pre-loaded into the SmartInserter, ready for immediate insertion. The SmartInserter is a single-use replacement device intended for anterograde insertion only.
Atos Medical AB
17 Fr
Not in Commercial Distribution

  • 07331791010095 ()

  • Length: 4 Millimeter
8110

  • Tracheoesophageal speech valve, indwelling
Provox2 is an indwelling, low resistance voice prosthesis intended for voice restoration after total laryngectomy. Provox2 is intended for both antero- and retrograde insertion at time of surgery or as replacement device.
Atos Medical AB
7219
In Commercial Distribution

  • 07331791010071 ()

  • Length: 10 Millimeter
7219

  • Tracheoesophageal speech valve, indwelling
Provox XtraFlange is a white silicone washer that is intended to be placed between the tracheal flange of the prosthesis and the tracheal mucosa. It provides an extra seal against periprosthetic leakage through the adherence of the thin silicone sheet to the tracheal mucosa. The device is supplied sterile and is intended for single use only.
Atos Medical AB
7277
In Commercial Distribution

  • 07331791006944 ()

  • Voice Prosthesis Compatibility Fits 17 Fr voice prosthesis
7277

  • Tracheoesophageal speech valve, indwelling
Provox XtraFlange is a white silicone washer that is intended to be placed between the tracheal flange of the prosthesis and the tracheal mucosa. It provides an extra seal against periprosthetic leakage through the adherence of the thin silicone sheet to the tracheal mucosa. The device is supplied sterile and is intended for single use only.
Atos Medical AB
7276
In Commercial Distribution

  • 07331791006937 ()

  • Voice Prosthesis Compatibility Fits 20 Fr voice prosthesis
7276

  • Tracheoesophageal speech valve, indwelling
Provox XtraFlange is a white silicone washer that is intended to be placed between the tracheal flange of the prosthesis and the tracheal mucosa. It provides an extra seal against periprosthetic leakage through the adherence of the thin silicone sheet to the tracheal mucosa. The device is supplied sterile and is intended for single use only.
Atos Medical AB
7275
In Commercial Distribution

  • 07331791006920 ()

  • Voice Prosthesis Compatibility Fits 22.5 Fr voice prosthesis
7275

  • Tracheoesophageal speech valve, indwelling
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
8304
In Commercial Distribution

  • 07331791011085 ()

  • Length: 12.5 Millimeter
  • Diameter Outer - Fr 22.5
8304

  • Tracheoesophageal speech valve, indwelling
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
8302
In Commercial Distribution

  • 07331791011061 ()

  • Length: 8 Millimeter
  • Diameter Outer - Fr 22.5
8302

  • Tracheoesophageal speech valve, indwelling
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
8301
In Commercial Distribution

  • 07331791011054 ()

  • Length: 6 Millimeter
  • Diameter Outer - Fr 22.5
8301

  • Tracheoesophageal speech valve, indwelling
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
8296
In Commercial Distribution

  • 07331791011009 ()

  • Length: 8 Millimeter
  • Diameter Outer - Fr 20
8296

  • Tracheoesophageal speech valve, indwelling
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
8295
In Commercial Distribution

  • 07331791010996 ()

  • Length: 6 Millimeter
  • Diameter Outer - Fr 20
8295

  • Tracheoesophageal speech valve, indwelling
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