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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 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
The Provox voice prosthesis system is intended for use of prosthetic voice restoration after total laryngectomy. The Provox Dilator 17 and 20 are used for dilating tracheo-esophageal (TE) punctures that shrinks very fast or are too narrow to insert the selected Provox voice prosthesis. The Dilator may also be used to temporarily block or stent the TE puncture.
Atos Medical AB
7123
In Commercial Distribution

  • 07331791000409 ()
7123

  • Tracheoesophageal fistula dilator, reusable
No Description
Atos Medical AB
8343
In Commercial Distribution

  • 07331791181184 ()
8343

  • Tracheoesophageal fistula dilator, reusable
Gutta percha plastic carrier obturator
US ENDODONTICS, LLC
EE5020O
In Commercial Distribution

  • 10810047644153 ()
  • 00810047644156 ()
EE5020O

  • Warm-bonded endodontic obturation system obturator
Gutta percha plastic carrier obturator
US ENDODONTICS, LLC
EE3520O
In Commercial Distribution

  • 10810047644122 ()
  • 00810047644125 ()
EE3520O

  • Warm-bonded endodontic obturation system obturator
Gutta percha plastic carrier obturator
US ENDODONTICS, LLC
EE3020O
In Commercial Distribution

  • 10810047644115 ()
  • 00810047644118 ()
EE3020O

  • Warm-bonded endodontic obturation system obturator
Gutta percha plastic carrier obturator
US ENDODONTICS, LLC
EE2520O
In Commercial Distribution

  • 10810047644108 ()
  • 00810047644101 ()
EE2520O

  • Warm-bonded endodontic obturation system obturator
Gutta percha plastic carrier obturator
US ENDODONTICS, LLC
EE2020O
In Commercial Distribution

  • 10810047644092 ()
  • 00810047644095 ()
EE2020O

  • Warm-bonded endodontic obturation system obturator
Pink gutta percha core thermal obturator
US ENDODONTICS, LLC
EE5020C
In Commercial Distribution

  • 10810047644085 ()
  • 00810047644088 ()
EE5020C

  • Warm-bonded endodontic obturation system obturator
Pink gutta percha core thermal obturator
US ENDODONTICS, LLC
EE4520C
In Commercial Distribution

  • 10810047644078 ()
  • 00810047644071 ()
EE4520C

  • Warm-bonded endodontic obturation system obturator
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