GN Otometrics A/S

GUDID 05713315001253

Gn Otometrics A/S

Hearing aid tester, electrical
Primary Device ID05713315001253
NIH Device Record Key39e96cc6-a8c5-413b-b228-14f04ebd156f
Commercial Distribution StatusIn Commercial Distribution
Brand NameGN Otometrics A/S
Version Model NumberRECD Fitting Kit
Company DUNS306633756
Company NameGn Otometrics A/S
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS105713315001253 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ETWCalibrator, Hearing Aid / Earphone And Analysis Systems

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-03-05
Device Publish Date2016-09-19

On-Brand Devices [GN Otometrics A/S]

05713315008184OTOair 2 Bluetooth Dongle
057133150060051093, Headset HS3
057133150058861093, Otoscan Instrument
05713315005701REM Tube with ruler
057133150056881096, SA CLINI W/O PRIN,CLAS US
057133150056711096, SA,CLINI W/O PRIN, COM US
057133150056641096, SA CLINI W/ PRIN,COM US
057133150056571096, SA,CLINI W/ PRIN, CLAS US
057133150056401096, SA,DIAG W/O PRIN,CLASS US
057133150056331096,SA, DIAG W/O PRIN,COM US
057133150056261096,SA, DIAG W/ PRIN,CLASS US
057133150056191096,SA, DIAG W/ PRIN, COM US
057133150056021096,SA, QUICKCHECK W/ PRIN, US
057133150055961096,SA, QUICKCHECK W/O PRIN, US
057133150055891096, PC CLINICAL COM US
057133150055721096, PC CLINICAL CLAS US
057133150055651096, PC, DIAGNOSTIC, CLASS, US
057133150055581096, PC, DIAGNOSTIC, COM, US
057133150055411096, PC, QUICKCHECK, US
057133150055341081 AURICAL w/o HI-PRO
057133150055271081 AURICAL with HI-PRO
05713315005497MADSEN AccuScreen, TE/DP
05713315005480MADSEN AccuScreen, DP
05713315005473MADSEN AccuScreen, TE
05713315005466NB71, Boneconductor w/headband and cable
057133150054591004, DIN TO JACK MALE ADAPTER
05713315005442ECC for EarHugs
057133150054351021, EAR TIP KIT,16 MM 50PCS
057133150054281021, EAR TIP KIT,12,5MM 50PCS
057133150054111021, EAR TIP KIT, 11MM 50PCS
057133150054041021, EAR TIP KIT, 9.5MM 50PCS
057133150053981021, EAR TIP KIT, 8MM 50PCS
057133150053741021, EAR TIP KIT, 6MM 50PCS
057133150053671021, EAR TIP KIT, 5MM 50PCS
05713315005343AS, TEST CAVITY, 1.75 CCM
05713315005336Earhugs, disposables
057133150052821085, VOLUME VISION DENIED BOX
057133150052681085, GOGGLE HOME KIT
057133150052441085 Vision Denied Solution Kit (50 sets)
057133150051831096, INSERT CONTRA PHONE
057133150051761096, CONTRA TDH39
057133150051691096, EARTIP STARTER KIT
057133150051521096, PROBE TIP KIT
057133150051451096, CALIBRATION CAVITY KIT
057133150051381096, 2CC TEST CAVITY
057133150051211096, DIAGNOSTIC PROBE,COMFORT
057133150051141096, DIAGNOSTIC PROBE,CLASSIC
057133150051071096, QUICK CHECK PROBE
057133150050911078, EARTIP STARTER KIT
05713315005084ENG CBL,7-LD,USED W/O PREAMP

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