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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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Ponto Pro, left, mocca brown
Oticon Medical AB
130-00-211-00
Not in Commercial Distribution

  • 05712149000104 ()
130-00-211-00

  • Anchored bone-conduction hearing implant system
Ponto Pro, left, chroma beige
Oticon Medical AB
130-00-210-00
Not in Commercial Distribution

  • 05712149000098 ()
130-00-210-00

  • Anchored bone-conduction hearing implant system
No Description
Sealcath, LLC
0006560
In Commercial Distribution

  • 10860000559130 ()
  • 00860000559133 ()

  • Catheter Gauge: 30 French


  • Barium enema catheter
  • Enema tip, single-use
No Description
Sealcath, LLC
0006560
In Commercial Distribution

  • 10860000559123 ()
  • 00860000559126 ()

  • Catheter Gauge: 20 French


  • Enema tip, single-use
  • Barium enema catheter
No Description
Sealcath, LLC
0006560
In Commercial Distribution

  • 10860000559116 ()
  • 00860000559119 ()

  • Catheter Gauge: 30 French


  • Barium enema catheter
  • Enema tip, single-use
No Description
Sealcath, LLC
0006560
In Commercial Distribution

  • 10860000559109 ()
  • 00860000559102 ()

  • Catheter Gauge: 20 French


  • Barium enema catheter
  • Enema tip, single-use
iOS application portion for Salux™ Tablet-Controlled Audiometer system. The Examinetics Tablet-Controlled Audiometer is an audiometer designed to be compliant with ANSI Standard 3.6. The Salux™ Audiometer will have the ability to interface with other software necessary for administering hearing screenings. The Salux™ Audiometer solution can be used to display video or static content to the participant.
Examinetics, Inc.
SALUX-SW-02
In Commercial Distribution

SALUX-SW-02

  • Tone audiometer, semi-automated
iOS application portion for Salux™ Tablet-Controlled Audiometer system. The Examinetics Tablet-Controlled Audiometer is an audiometer designed to be compliant with ANSI Standard 3.6. The Salux™ Audiometer will have the ability to interface with other software necessary for administering hearing screenings. The Salux™ Audiometer solution can be used to display video or static content to the participant.
Examinetics, Inc.
SALUX-SW-01
In Commercial Distribution

  • 00860007826627 ()
SALUX-SW-01

  • Tone audiometer, semi-automated
Headphone portion for Salux™ Tablet-Controlled Audiometer. The Examinetics Tablet-Controlled Audiometer is an audiometer designed to be compliant with ANSI standard 3.6. The Salux™ Audiometer will have the ability to interface with other software necessary for administering hearing screenings. The Salux™ Audiometer solution can be used to display video or static content to the participant.
Examinetics, Inc.
SALUX-HP-01
In Commercial Distribution

  • 00860007826610 ()
SALUX-HP-01

  • Tone audiometer, semi-automated
Bluetooth audiometer portion of Salux™ Tablet-Controlled Audiometer. The Examinetics Tablet-Controlled Audiometer is an audiometer designed to be compliant with ANSI Standard 3.6. The Salux™ Audiometer will have the ability to interface with other software necessary for administering hearing screenings. The Salux™ Audiometer solution can be used to display video or static content to the participant.
Examinetics, Inc.
SALUX-AU-01
In Commercial Distribution

  • 00860007826603 ()
SALUX-AU-01

  • Tone audiometer, semi-automated
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