FDA.reportPublic FDA data

GN Otometrics A/S

Primary DI
05713315001161
Brand
GN Otometrics A/S
Company
Natus Medical Denmark ApS
Model
REM Test tubes, 1.1mm (50 pcs.)
Published
2016-09-26
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
ETWCalibrator, Hearing Aid / Earphone And Analysis Systems

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ETWCalibrator, Hearing Aid / Earphone And Analysis SystemsEar, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K110286000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K110286000GN OTOMETRICS TYPE 1053 FREEFITGn Otometrics A/S2011-04-28ETW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05713315001161PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05713315001161057133150011615713315001161

GMDN Terms#

Term, Definition table
TermDefinition
Hearing aid tester, electricalAn assembly of electronic reference devices intended to calibrate and assess the electroacoustic frequency and sound intensity characteristics emanating from a hearing aid, master hearing aid, group hearing aid, or group auditory trainer. The device typically consists of an acoustic complex of known cavity volume, a sound level meter, a microphone, oscillators, frequency counters, microphone amplifiers, a distortion analyser, a chart recorder, and a hearing aid test box. It is intended to be used by a healthcare provider (i.e., clinical technician) in a clinical setting.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
306633756
Device count
1
DM exempt
true
Lot or batch
true
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
057133150123581082 Aurical HITNatus Medical Denmark ApSETW2026-10-28
057133150123651053 Aurical FreefitNatus Medical Denmark ApSETW2026-10-28
05713315012389GN Otometrics A/SNatus Medical Denmark ApSETW2026-10-28
057133150123961053 Aurical FreefitNatus Medical Denmark ApSETW2026-10-28
057133150124021053 Aurical FreeFitNatus Medical Denmark ApSETW2026-10-28
057133150124261053 AUrical FreefitNatus Medical Denmark ApSETW2026-10-28
057133150124331053 Aurical FreefitNatus Medical Denmark ApSETW2026-10-28
05713315012532GN Otometrics A/SNatus Medical Denmark ApSETW2026-10-28
05711781004297Measure by Otometrics - HITAuditdata A/SETW2025-11-14
05711781004372Measure by Otometrics - HITAuditdata A/SETW2025-11-14
05711781004006Unity 3Auditdata A/SETW2024-10-21
05711117244335Sanibel Supply A/SInteracoustics A/SETW2024-10-07
05711117228458Sanibel Supply A/SInteracoustics A/SETW2024-10-07
00810044583182MedRxMEDRX, INC.ETW2024-05-07
EADF03410600217207189audifonaudifon GmbH & Co. KGETW2023-03-31
05711117121742Sanibel Supply A/SInteracoustics A/SETW2022-12-29
05711117094206Sanibel Supply A/SInteracoustics A/SETW2022-12-29
05711117226478Sanibel Supply A/SInteracoustics A/SETW2022-12-29
05711117227550Sanibel Supply A/SInteracoustics A/SETW2022-11-29
05711117227574Sanibel Supply A/SInteracoustics A/SETW2022-11-29
05711117227581Sanibel Supply A/SInteracoustics A/SETW2022-11-29
05711117228557Sanibel Supply A/SInteracoustics A/SETW2022-11-29
05711117228564Sanibel Supply A/SInteracoustics A/SETW2022-11-29
05711117228571Sanibel Supply A/SInteracoustics A/SETW2022-11-29
EADF034106002172068681audifonaudifon GmbH & Co. KGETW2022-10-21
05713315009037NatusNatus Medical Denmark ApSETW2021-04-12
05713315009044NatusNatus Medical Denmark ApSETW2021-04-12
05713315009051NatusNatus Medical Denmark ApSETW2021-04-12
05713315008689NatusNatus Medical Denmark ApSETW2021-01-04
B161RE3670Audioscan Probe TubeEtymonic Design IncorporatedETW2020-01-15