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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 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 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
8293
In Commercial Distribution

  • 07331791010972 ()

  • Length: 15 Millimeter
  • Diameter Outer - Fr 17
8293

  • 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
8292
In Commercial Distribution

  • 07331791010965 ()

  • Length: 12.5 Millimeter
  • Diameter Outer - Fr 17
8292

  • 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
8291
In Commercial Distribution

  • 07331791010958 ()

  • Length: 10 Millimeter
  • Diameter Outer - Fr 17
8291

  • 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
8290
In Commercial Distribution

  • 07331791010941 ()

  • Length: 8 Millimeter
  • Diameter Outer - Fr 17
8290

  • 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
8289
In Commercial Distribution

  • 07331791010934 ()

  • Length: 6 Millimeter
  • Diameter Outer - Fr 17
8289

  • 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
8288
In Commercial Distribution

  • 07331791010927 ()

  • Length: 4 Millimeter
  • Diameter Outer - Fr 17
8288

  • Tracheoesophageal speech valve, indwelling
InSpace™ system, Large The InSpace™ Subacromial Tissue Spacer System is a Shoulder spacer for massive irreparable rotator cuff tears, resorbable, inflatable, non-fixed. The InSpace™ Subacromial Tissue Spacer System implant is designed to act as a spacer, creating a physical barrier between tissues in the subacromial space. It is supplied sterile (EtO) and intended for single use.
ORTHO-SPACE LTD
0132
In Commercial Distribution

  • 17290013396065 ()
0132

  • Tendon spacer
InSpace™ system, Medium The InSpace™ Subacromial Tissue Spacer System is a Shoulder spacer for massive irreparable rotator cuff tears, resorbable, inflatable, non-fixed. The InSpace™ Subacromial Tissue Spacer System implant is designed to act as a spacer, creating a physical barrier between tissues in the subacromial space. It is supplied sterile (EtO) and intended for single use.
ORTHO-SPACE LTD
0131
In Commercial Distribution

  • 17290013396058 ()
0131

  • Tendon spacer
InSpace™ system Small The InSpace™ Subacromial Tissue Spacer System is a Shoulder spacer for massive irreparable rotator cuff tears, resorbable, inflatable, non-fixed. The InSpace™ Subacromial Tissue Spacer System implant is designed to act as a spacer, creating a physical barrier between tissues in the subacromial space. It is supplied sterile (EtO) and intended for single use.
ORTHO-SPACE LTD
0130
In Commercial Distribution

  • 17290013396041 ()
0130

  • Tendon spacer
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