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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 Power, left, mocca brown
Oticon Medical AB
M50873
Not in Commercial Distribution

  • 05712149002849 ()
M50873

  • Anchored bone-conduction hearing implant system
Ponto Pro Power, right, mocca brown
Oticon Medical AB
M50872
Not in Commercial Distribution

  • 05712149002832 ()
M50872

  • Anchored bone-conduction hearing implant system
eCoin Aftercare Kit
Valencia Technologies Corporation
1011-2813
In Commercial Distribution

  • 00860007896941 ()


  • Wound dressing kit, non-medicated, non-sterile
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
ASTM Level 3 Surgical Mask - Box of 50 -
Taiji Medical Supplies Inc.
A1
In Commercial Distribution

  • 10860007355902 ()
  • 00860007355905 ()
  • 00860007355950 ()

  • Length: 175 Millimeter
  • Width: 95 Millimeter
16752

  • Surgical/medical face mask, single-use
The Defender Safety Procedure and Surgical Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce potential exposure to blood and body fluids. The face mask is single-use, disposable device, provided non-sterile.
Defender Safety Inc.
DSM-SM03-B
In Commercial Distribution

  • 00860007209536 ()
DSM-SM03-B

  • Surgical/medical face mask, single-use
The Defender Safety Procedure and Surgical Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce potential exposure to blood and body fluids. The face mask is single-use, disposable device, provided non-sterile.
Defender Safety Inc.
DSM-PM03-B
In Commercial Distribution

  • 00860007209529 ()
DSM-PM03-B

  • Surgical/medical face mask, single-use
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