FDA.reportPublic FDA data

GN Otometrics A/S

Primary DI
05713315002649
Brand
GN Otometrics A/S
Company
Natus Medical Denmark ApS
Model
"Disposable Electrode 24"" Wired Qty 10"
Published
2016-09-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
GWNNystagmograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWNNystagmographNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K061791000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K061791000FOCUS VNG/ENG TYPE 1068Gn Otometrics A/S2006-07-11GWN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05713315002649PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05713315002649057133150026495713315002649

GMDN Terms#

Term, Definition table
TermDefinition
Auditory stimulatorA mains electricity (AC-powered) device that applies sound stimuli (e.g., pure tones, speech) to a patient's acoustic system. It is typically used as a component of several types of devices such as audiometers, auditory evoked-potential recording systems, and auditory function screening devices.

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
05713315009426Madsen Zodiac8-04-163038-04-163032026-06-03
05713315009433Madsen Zodiac8-04-163048-04-163042026-06-03
05713315009457Madsen Zodiac8-04-163068-04-163062026-06-03
05713315009471Madsen Zodiac8-04-163088-04-163082026-06-03
05713315009488Madsen Zodiac8-04-163098-04-163092026-06-03
05713315009501Madsen Zodiac8-04-163118-04-163112026-06-03
05713315009518Madsen Zodiac8-04-163128-04-163122026-06-03
05713315009525Madsen Zodiac8-04-163138-04-163132026-06-03
05713315009532Madsen Zodiac8-04-163148-04-163142026-06-03
05713315009556Madsen Zodiac8-04-163168-04-163162026-06-03
05713315009570Madsen Zodiac8-04-163188-04-163182026-06-03
05713315009402Madsen Zodiac8-04-163012026-06-02
05713315008474Otometrics1085, FACE CUSHION 2 ASM KIT8-35-501002020-06-02
05713315008443Otometrics1085, STRAP ASSEMBLY8-35-342002019-11-20
05713315008467Otometrics1085, FACE PAD ASSEMBLY KIT V28-35-393002020-05-18
05713315003295OtometricsGoggle face cushion kit2019-04-24
05713315005268GN Otometrics A/S1085, GOGGLE HOME KIT2016-09-23
05713315002915GN Otometrics A/SDisposable Diff VEMP Electrode2019-04-01
05713315000874GN Otometrics A/SOTOair Bluetooth Dongle2016-09-19
05713315011597RetCam Envision61-00030061-0003002026-02-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B516327270Instrumentation Difra SAInstrumentation Difra SAGWN2026-03-09
05711117244991InteracousticsInteracoustics A/SGWN2025-08-14
05711117245004InteracousticsInteracoustics A/SGWN2025-08-14
05711117245028InteracousticsInteracoustics A/SGWN2025-08-14
00860013612900EYE-SYNCNEUROSYNC INC.GWN2025-03-12
B516325950Instrumentation Difra SAInstrumentation Difra SAGWN2025-03-12
B516326290Instrumentation Difra SAInstrumentation Difra SAGWN2025-03-12
B516326380Instrumentation Difra SAInstrumentation Difra SAGWN2025-03-12
057133150107361091, ICS Dizcovery SystemNatus Medical Denmark ApSGWN2025-02-21
057133150108111091, ICS Dizcovery ShadeShift Panels Natus Medical Denmark ApSGWN2025-02-21
057133150108281091, ICS Dizcovery LCD PanelsNatus Medical Denmark ApSGWN2025-02-21
057133150108801091, ICS Dizcovery Universal Face Cushion (qty 40)Natus Medical Denmark ApSGWN2025-02-21
08054187380815Synapsys VHITINVENTIS SRLGWN2025-01-08
08054187380822Synapsys VHITINVENTIS SRLGWN2025-01-08
B366VN1061R00VNG 3DEclerisGWN2024-12-17
05713315007132GN Otometrics A/SNatus Medical Denmark ApSGWN2024-12-04
08054187380983VNGINVENTIS SRLGWN2024-10-01
08054187380990VNGINVENTIS SRLGWN2024-10-01
08054187381003VNGINVENTIS SRLGWN2024-10-01
08054187381010VNGINVENTIS SRLGWN2024-10-01
08054187381027VNGINVENTIS SRLGWN2024-10-01
08054187381034VNGINVENTIS SRLGWN2024-10-01
08054187381041VNGINVENTIS SRLGWN2024-10-01
08054187381058VNGINVENTIS SRLGWN2024-10-01
08054187381065VNGINVENTIS SRLGWN2024-10-01
B516308640Instrumentation Difra SAInstrumentation Difra SAGWN2024-08-19
B366VN1061VNG 3DEclerisGWN2024-05-20
20763000467344NAMEDTRONIC PS MEDICAL, INC.GWN2024-03-01
00763000467340NAMEDTRONIC PS MEDICAL, INC.GWN2024-03-01
20763000467351NAMEDTRONIC PS MEDICAL, INC.GWN2024-02-26