FDA.reportPublic FDA data

OtoNova Pro Fabric Carry Case

Primary DI
05060396173738
Brand
OtoNova Pro Fabric Carry Case
Company
OTODYNAMICS LIMITED
Model
NPRO-CAS
Device description
Lightweight carry case for the OtoNova Pro kit, with sections for OtoNova Pro, charger, wireless charging pad, probes, probe tips box and test cavity. Handy compartments inside and outside for documentation and pens. Detachable shoulder strap. Dimensions: 325mm x 265mm x 100mm
Published
2024-08-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
K234095000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K234095000OtoNova/OtoNova ProOtodynamics2024-06-21EWO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060396173738PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060396173738050603961737385060396173738

GMDN Terms#

Term, Definition table
TermDefinition
Otoacoustic emission system, battery-poweredAn assembly of battery-powered devices designed to record and analyse the faint sounds hair cells in the inner ear emit [otoacoustic emission (OAE)] in response to a stimulus (e.g., click, tone burst, pure-tone signals) to test for a deficiency of function in the ear during diagnostic evaluation and/or neonatal screening. It typically consists of a portable programmable unit, an OAE probe, and eartips. The stimulus signal is emitted via the probe inserted into the ear canal and the response is recorded via a microphone in the probe; OAEs are absent/reduced in patients with hearing loss. The system may be combined with other audiological devices (e.g., tympanometer, ABR device).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-659-7776info@otodynamics.com

Regulatory Flags#

DUNS number
235908050
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060396171130Crib/bassinet device holster for OtoNovaNOVA-CRIB2024-08-20
05060396171512Tablet Computer for OtoNova Pro NOVA-TABLET2024-08-20
05060396171529OtoNova ChargerNOVA-CHG2024-08-20
05060396171536OtoNova Wireless Charging PadNOVA-CHG-PAD2024-08-20
05060396172243XPD Ear ProbePR-XPD2024-08-20
05060396172359ABR Electrode Cable (SNAP) for OtoNova ProNPRO-SEC2024-08-20
05060396172366ABR Electrode Cable (TAB) for OtoNova ProNPRO-TEC2024-08-20
05060396172809OtoNova Battery Assembly Service KitON-BATT-KIT2024-08-20
05060396173011OtoNova Pro OAE+AABR instrumentOTONOVAPRO2024-08-20
05060396173042OtoNova Pro Main PCB Service KitON2-MAIN2024-08-20
05060396173059OtoNova Pro Charger PCB Service KitON2-CHG-KIT2024-08-20
05060396173080OtoNova Pro Case Service KitON2-CASE-KIT2024-08-20
05060396173103OtoNova Pro Screener TENPRO-SCR-T2024-08-20
05060396173110OtoNova Pro Screener DPNPRO-SCR-D2024-08-20
05060396173127OtoNova Pro Screener AABRNPRO-SCR-A2024-08-20
05060396173134OtoNova Pro Screener DP+TENPRO-SCR-DT2024-08-20
05060396173141OtoNova Pro Screener TE+AABRNPRO-SCR-TA2024-08-20
05060396173158OtoNova Pro Screener DP+AABRNPRO-SCR-DA2024-08-20
05060396173165OtoNova Pro Screener DP+TE+AABRNPRO-SCR-DTA2024-08-20
05060396173172OtoNova Pro Clinical+TE+AABRNPRO-CLN-DTA2024-08-20

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Primary DI, Brand, Company table
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057133150007681052 OTOsuiteNatus Medical Denmark ApSEWO2026-06-22
00817020020723Screener CartINTELLIGENT HEARING SYSTEMS CORP.EWO2026-06-10
00817020020723Screener CartINTELLIGENT HEARING SYSTEMS CORP.GWJ2026-06-10
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