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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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AccuQuest - 05711584088708

AQ CO3 MNR T, 2.4G NFM DPB MAC/MSIL ACCUQ
Bernafon AG
192784
In Commercial Distribution

  • 05711584088708 ()


  • Air-conduction hearing aid, receiver-in-the-ear

AccuQuest - 05711584088692

AQ CO3 MNR T, 2.4G NFM DPB MSIL ACCUQ
Bernafon AG
192783
In Commercial Distribution

  • 05711584088692 ()


  • Air-conduction hearing aid, receiver-in-the-ear

AccuQuest - 05711584088685

AQ CO3 MNR T, 2.4G NFM DPB SABE/MSIL ACCUQ
Bernafon AG
192782
In Commercial Distribution

  • 05711584088685 ()


  • Air-conduction hearing aid, receiver-in-the-ear

Costco - 05711584088555

CAPTO 1 MNR T, 2.4G NFM DPB SABE/MSIL DEMO COSTC
Bernafon AG
192962
In Commercial Distribution

  • 05711584088555 ()


  • Air-conduction hearing aid, receiver-in-the-ear

Costco - 05711584088548

CAPTO 3 MNR T, 2.4G NFM DPB SABE/MSIL DEMO COSTC
Bernafon AG
192961
In Commercial Distribution

  • 05711584088548 ()


  • Air-conduction hearing aid, receiver-in-the-ear

Costco - 05711584088531

CAPTO 1 MNR, 2.4G NFM PB SABE/MSIL DEMO COSTC
Bernafon AG
192960
In Commercial Distribution

  • 05711584088531 ()


  • Air-conduction hearing aid, receiver-in-the-ear

Tupel 3D - 00860007842931

An optical 3D dental implant scanner
TUPEL LTD
Optical 3D Implant Scanner
In Commercial Distribution

  • 00860007842931 ()


  • Dental milling system, CAD/CAM, chairside

Tupel 3D - 00860007842900

A 3D desktop dental scanner
TUPEL LTD
Desktop 3D Dental Scanner
In Commercial Distribution

  • 00860007842900 ()


  • Dental milling system, CAD/CAM, chairside

HEMIGARD Interlock - 00860007834226

One hemigard hook strap and one hemigard loop piece
Suturegard Medical Inc
HRD002
In Commercial Distribution

  • 10860007834223 ()
  • 00860007834226 ()
HRD002

  • Skin-closing tension device

Salux™ - 00860007826641

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
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