FDA.reportPublic FDA data

GN Otometrics A/S

Primary DI
05713315007132
Brand
GN Otometrics A/S
Company
Natus Medical Denmark ApS
Model
ICS Impulse
Published
2024-12-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GWNNystagmograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWNNystagmographNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05713315007132PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05713315007132057133150071325713315007132

GMDN Terms#

Term, Definition table
TermDefinition
ElectronystagmographA graphic recorder used for detecting the electrical potential caused by eye movements. This recorder includes an electrode for each eye and one on the forehead (multichannel recording) for measuring the potential from both eyes simultaneously, or repositioning of the electrodes before each test for single channel recording. Electronystagmographs are used for detecting multiple sclerosis, vestibular dysfunctions, the presence of drugs and other specific disorders characterized by involuntary eye movement (nystagmus).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
306633756
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05713315009051Natus8-62-453008-62-453002021-04-12
05713315008689Natus1053 Freefit Charger8-62-393032021-01-04
05713315005848GN Otometrics A/SProbe Tube Holder mk28-62-608002019-04-24
05713315000874GN Otometrics A/SOTOair Bluetooth Dongle8-62-415032016-09-19
05713315001055GN Otometrics A/SFreeFit REM probe8-69-392032016-09-19
05713315001192GN Otometrics A/SPMM RECD Probe Short8-69-392072016-09-19
05713315001208GN Otometrics A/SPMM RECD Probe Long8-69-392082016-09-19
05713315001215GN Otometrics A/SPMM RECD Probe Bin Long8-69-392092016-09-19
05713315001222GN Otometrics A/SPMM RECD Probe Bin Short8-69-392102016-09-19
05713315001246GN Otometrics A/SRECD Eartip Kit1-25-139042016-09-19
05713315001253GN Otometrics A/SRECD Fitting Kit8-62-490002016-09-19
05713315001277GN Otometrics A/SSoundHub 1008-62-423002016-09-26
05713315003301GN Otometrics A/SREM Test tubes, 1.1mm (50 pcs.)8-62-351002018-07-31
05713315004100GN Otometrics A/SAurical FreeFit, Complete Solution8-04-118082016-09-19
05713315004117GN Otometrics A/SAurical FreeFit, Complete Solution8-62-491002016-09-19
05713315005701GN Otometrics A/SREM Tube with ruler8-62-610002018-11-06
05713315008184GN Otometrics A/SOTOair 2 Bluetooth Dongle8-62-649002019-03-18
00571331500960Madsen Zodiac8-04-163218-04-163212026-06-04
05713315009587Madsen Zodiac8-04-163198-04-163192026-06-04
05713315009594Madsen Zodiac8-04-163208-04-163202026-06-04

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
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
20763000467382NAMEDTRONIC PS MEDICAL, INC.GWN2024-02-26