FDA.reportPublic FDA data

Grason-Stadler

Primary DI
00810046701690
Brand
Grason-Stadler
Company
Diagnostic Group LLC
Model
GSI AMTAS Flex
Published
2023-03-07
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810046701690PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810046701690008100467016908100467016900810046701690

GMDN Terms#

Term, Definition table
TermDefinition
Pure-tone audiometerAn electroacoustic device that generates tones throughout the audible range (usually at each octave between 125 Hz and 8 kHz) at amplitudes related to the expected thresholds for a normally hearing person, and presents them to a patient, typically one ear at a time with headphones, to evaluate hearing. The difference between the patient threshold and the normal (i.e., the hearing loss) is typically recorded on an audiogram chart in decibels. The device may be equipped with a bone vibrator for direct inner-ear stimulation to corroborate hearing loss. A masking tone system is necessary for testing if there is a large difference in hearing between the ears.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
175799717
Device count
1
Premarket exempt
true
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00817020020723Screener CartINTELLIGENT HEARING SYSTEMS CORP.EWO2026-06-10
00817020021027Toy Cabinet (Small)INTELLIGENT HEARING SYSTEMS CORP.EWO2026-06-10
00817020021034Bone Vibrator w/Cable and Headband (B71)INTELLIGENT HEARING SYSTEMS CORP.EWO2026-06-10
00817020021089DD45-300 Headphones with Pediatric HeadbandINTELLIGENT HEARING SYSTEMS CORP.EWO2026-06-10
00817020021096DD45-300 Headphones with Easy Adjust HeadbandINTELLIGENT HEARING SYSTEMS CORP.EWO2026-06-10
00817020021133OAE Probe OP23INTELLIGENT HEARING SYSTEMS CORP.EWO2026-06-10
00817020021140Diagnostic CartINTELLIGENT HEARING SYSTEMS CORP.EWO2026-06-10
00817020021218DD450 HF HeadphonesINTELLIGENT HEARING SYSTEMS CORP.EWO2026-06-10
00817020021225DD45S (10 Ohms) HeadphonesINTELLIGENT HEARING SYSTEMS CORP.EWO2026-06-10
00817020021232DD45S (10 Ohms) Headphones with Pediatric HeadbandINTELLIGENT HEARING SYSTEMS CORP.EWO2026-06-10
00817020021249DD45S (10 Ohms) Headphones with Easy Adjust HeadbandINTELLIGENT HEARING SYSTEMS CORP.EWO2026-06-10
00817020020280Capella2 OAE Start-Up KitINTELLIGENT HEARING SYSTEMS CORP.EWO2026-06-09
00817020021003B81 Bone VibratorINTELLIGENT HEARING SYSTEMS CORP.EWO2026-06-09
00817020021010B81 Bone Vibrator CableINTELLIGENT HEARING SYSTEMS CORP.EWO2026-06-09
00817020021164Bone Vibrator w/Cable and Headband (B81) for AriaINTELLIGENT HEARING SYSTEMS CORP.EWO2026-06-09
00817020021171Bone Vibrator Cable for AriaINTELLIGENT HEARING SYSTEMS CORP.EWO2026-06-09
00810046707562Grason-StadlerDiagnostic Group LLCEWO2026-06-04
05745000311064OscillaOscilla A/SEWO2026-05-29
05745000311095OscillaOscilla A/SEWO2026-05-29
05745000311156OscillaOscilla A/SEWO2026-05-29
05745000311163OscillaOscilla A/SEWO2026-05-29