FDA.reportPublic FDA data

Grason-Stadler

Primary DI
08584270041076
Brand
Grason-Stadler
Company
Diagnostic Group LLC
Model
GSI Audera
Published
2016-11-10
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
EWOAudiometer
GWJStimulator, Auditory, Evoked Response

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EWOAudiometerEar, Nose, Throat2
GWJStimulator, Auditory, Evoked ResponseNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08584270041076PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08584270041076085842700410768584270041076

GMDN Terms#

Term, Definition table
TermDefinition
Evoked-potential audiometerAn electroacoustic instrument designed to evaluate the activity of the auditory pathway of the brain in response to an acoustic signal [auditory brainstem response (ABR)] it provides at the ear (e.g., clicks delivered through an earphone), without need of patient cooperation. The signal, detected via the device's scalp electrodes and possibly a reference electrode on the ear lobe, is measured using computer averaging and signal processing techniques. This device is typically used to assess the function of the auditory pathways and to differentiate coma due to metabolic factors from structural damage.

Regulatory Flags#

DUNS number
175799717
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810046707562Grason-StadlerGSI AudioHub2026-06-04
00810046707180Grason-StadlerGSI AudioHub2026-04-06
08584270045074MaicoEroScan2018-07-24
00810046700006Grason-StadlerGSI 182016-11-10
00810046700075Grason-StadlerGSI Pello2016-11-28
00810046700129Grason-StadlerGSI Novus2017-10-24
00810046700235Grason-StadlerGSI AMTAS Flex2017-07-26
00810046700266Grason-StadlerGSI AMTAS Flex2017-11-29
00810046700273Grason-StadlerGSI AMTAS Flex2017-11-29
00810046700488Grason-StadlerGSI AudioStar Pro2018-10-22
08584270041069Grason-StadlerGSI AudioStar Pro2016-11-10
08584270041106TremetricsRA8002016-11-10
08584270041151MaicoMA 42 2016-11-10
08584270041168MaicoMA 522016-09-24
08584270041267MaicoMA 272016-11-10
08584270041298MaicoDigital Pilot Test 2016-11-10
08584270041311TremetricsRA3002016-11-10
08584270041328TremetricsHT Wizard Ultra2016-11-10
08584270041526MaicoMA 12016-11-10
08584270041533MaicoMA 252016-11-10

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Primary DI, Brand, Company table
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04260223147975PIEP (2x2)PATH medical GmbHEWO2026-07-24
04260223147975PIEP (2x2)PATH medical GmbHGWJ2026-07-24
04260223148002Accessory box AB-LT02PATH medical GmbHGWJ2026-07-24
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05713315006906Madsen AccuscreenNatus Medical Denmark ApSGWJ2026-07-08
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057133150000581052 OTOsuiteNatus Medical Denmark ApSEWO2026-06-22
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057133150007681052 OTOsuiteNatus Medical Denmark ApSEWO2026-06-22
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