FDA.reportPublic FDA data

GN Otometrics A/S

Primary DI
05713315008252
Brand
GN Otometrics A/S
Company
Natus Medical Denmark ApS
Model
Insert Earphone Tube Tips
Published
2019-04-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EWOAudiometer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EWOAudiometerEar, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K081234000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K081234000GN OTOMETRICS INSERT EARPHONESGn Otometrics2008-07-14EWO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05713315008252PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05713315008252057133150082525713315008252

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
306633756
Device count
1
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
057133150123581082 Aurical HIT9-04-151019-04-151012026-10-28
057133150123651053 Aurical Freefit9-62-491009-62-491002026-10-28
05713315012389GN Otometrics A/S1053 PMM, RECD Probe, Long (2pcs)9-69-392102026-10-28
057133150123961053 Aurical Freefit9-04-118089-04-118082026-10-28
057133150124021053 Aurical FreeFit9-62-453009-62-453002026-10-28
057133150124261053 AUrical Freefit9-04-118209-04-118202026-10-28
057133150124331053 Aurical Freefit9-62-491109-62-491102026-10-28
057133150124401081 Aurical Aud9-04-145309-04-145302026-10-28
05713315012532GN Otometrics A/S1053 PMM RECD Probe, Long9-69-392062026-10-28
05713315010996AccuScreen Earcouplers0465850465852026-10-14
05713315011009AccuScreen Earcouplers0462000462002026-10-14
05713315012297Disposable Snap Electrodes (25 x 3 pack)0521630521632026-10-14
05713315012303Disposable Snap Electrodes (3 pack)0521650521652026-10-14
05713315000331GN Otometrics A/SHearing Instrument Programmer8-04-148002016-09-17
05713315012341Aurical Otocam 300-III10768-04-132602026-07-20
05713315006890Madsen Accsucreen8-04-139778-04-139772026-07-08
05713315006906Madsen Accuscreen8-04-139788-04-139782026-07-08
05713315008610Natus8-31-2008-31-2002020-12-16
05713315008627Natus8-31-190028-31-190022020-12-16
05713315000713GN Otometrics A/SPatient Responder (Red)8-31-1902016-09-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
057133150124401081 Aurical AudNatus Medical Denmark ApSEWO2026-10-28
08806099222635Hearing Test FeatureSamsung Electronics Co., Ltd.EWO2026-10-19
00810046707265Grason-StadlerDiagnostic Group LLCEWO2026-09-29
04262406074184MaicoMAICO Diagnostics GmbHEWO2026-09-29
04262406074207MaicoMAICO Diagnostics GmbHEWO2026-09-29
G860TELEDX0TELE-DXHear.com LLCEWO2026-09-25
05711117244540InteracousticsInteracoustics A/SEWO2026-07-28
05711117244557InteracousticsInteracoustics A/SEWO2026-07-28
04260223147579Infant Insert Eartips 4.0mm (bag of 20)PATH medical GmbHEWO2026-07-24
04260223147586Infant Insert Eartips 3.5mm (bag of 20)PATH medical GmbHEWO2026-07-24
04260223147654Bone Conductor BC-2LDPATH medical GmbHEWO2026-07-24
04260223147661Bone Conductor BC-2LDPATH medical GmbHEWO2026-07-24
04260223147678Bone Conductor BC-2LDPATH medical GmbHEWO2026-07-24
04260223147975PIEP (2x2)PATH medical GmbHEWO2026-07-24
057133150000581052 OTOsuiteNatus Medical Denmark ApSEWO2026-06-22
057133150007511066 OTOsuiteNatus Medical Denmark ApSEWO2026-06-22
057133150007681052 OTOsuiteNatus Medical Denmark ApSEWO2026-06-22
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