FDA.reportPublic FDA data

Grason-Stadler

Primary DI
00810046707265
Brand
Grason-Stadler
Company
Diagnostic Group LLC
Model
GSI Novus
Published
2026-09-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172403000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172403000GSI NovusGrason-Stadler, Inc.2017-10-20EWO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810046707265PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810046707265008100467072658100467072650810046707265

GMDN Terms#

Term, Definition table
TermDefinition
Tone audiometerAn electroacoustic device intended for use in a clinical setting to generate tones in the audible range to measure the hearing threshold of a patient by establishing the level at which the patient first becomes aware of the sounds. The device controls tone intensity and frequency either by a computer or manually, and displays/records the patient's responses, typically in the form of an audiogram. It may include a bone vibrator for direct inner-ear stimulation.

Regulatory Flags#

DUNS number
175799717
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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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05711117244540InteracousticsInteracoustics A/SGWJ2026-07-28
05711117244540InteracousticsInteracoustics A/SEWO2026-07-28
05711117244557InteracousticsInteracoustics A/SEWO2026-07-28
05711117244557InteracousticsInteracoustics A/SGWJ2026-07-28
04260223145995Ear Coupler SetPATH medical GmbHGWJ2026-07-24
04260223147579Infant Insert Eartips 4.0mm (bag of 20)PATH medical GmbHGWJ2026-07-24
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
04260223147586Infant Insert Eartips 3.5mm (bag of 20)PATH medical GmbHGWJ2026-07-24
04260223147654Bone Conductor BC-2LDPATH medical GmbHEWO2026-07-24
04260223147654Bone Conductor BC-2LDPATH medical GmbHGWJ2026-07-24
04260223147661Bone Conductor BC-2LDPATH medical GmbHGWJ2026-07-24
04260223147661Bone Conductor BC-2LDPATH medical GmbHEWO2026-07-24
04260223147678Bone Conductor BC-2LDPATH medical GmbHEWO2026-07-24
04260223147678Bone Conductor BC-2LDPATH medical GmbHGWJ2026-07-24
04260223147746Ear Coupler TRPATH medical GmbHGWJ2026-07-24
04260223147975PIEP (2x2)PATH medical GmbHGWJ2026-07-24
04260223147975PIEP (2x2)PATH medical GmbHEWO2026-07-24
04260223148002Accessory box AB-LT02PATH medical GmbHGWJ2026-07-24
05713315006890Madsen AccsucreenNatus Medical Denmark ApSGWJ2026-07-08
05713315006906Madsen AccuscreenNatus Medical Denmark ApSGWJ2026-07-08
00860016073401Evoke EEG SystemFirefly Neuroscience, Inc.GWJ2026-07-07
00860016073418Evoke EEG System AmplifierFirefly Neuroscience, Inc.GWJ2026-07-07
057133150000581052 OTOsuiteNatus Medical Denmark ApSEWO2026-06-22
057133150007511066 OTOsuiteNatus Medical Denmark ApSEWO2026-06-22