FDA.reportPublic FDA data

UGD/UPD Probe Body & Lid (BLUE) PK 10

Primary DI
05060396171383
Brand
UGD/UPD Probe Body & Lid (BLUE) PK 10
Company
OTODYNAMICS LIMITED
Model
BGDL
Device description
Replacement probe head casing body and lid for UGD/UPD (Left-ear identification) probes
Published
2019-10-25
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EWOAudiometerEar, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K143395000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143395000Otoport OAE +ABR Advance, Otoport OAE+ABR DP+TE, Otoport OAE+ABR Screener-Otocheck OAE+ABR, Otocheck OAE+ABR LE, Otocheck ABR Screener-Otodynamics ABR Upgrade KitOtodynamics, Ltd.2015-02-23EWO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060396171383PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060396171383050603961713835060396171383

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1 800 659 7776enquiries@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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05745000311064OscillaOscilla A/SEWO2026-05-29
05745000311095OscillaOscilla A/SEWO2026-05-29
05745000311156OscillaOscilla A/SEWO2026-05-29
05745000311163OscillaOscilla A/SEWO2026-05-29
05745000311187OscillaOscilla A/SEWO2026-05-29
05745000311200OscillaOscilla A/SEWO2026-05-29
00810046707180Grason-StadlerDiagnostic Group LLCEWO2026-04-06
057117810041053000 Real EarAuditdata A/SEWO2026-01-23
057117810041363000 Real EarAuditdata A/SEWO2026-01-23
057117810041433000 Real EarAuditdata A/SEWO2026-01-23
057117810041503000 Real EarAuditdata A/SEWO2026-01-23
057117810041673000 Real EarAuditdata A/SEWO2026-01-23
057117810041743000 Real EarAuditdata A/SEWO2026-01-23
B43056000011110GoCheckGobiquity, Inc.EWO2026-01-09
B43056000011100GoCheckGobiquity, Inc.EWO2025-12-02
05060753520090Tympa Otoscope SystemTYMPA HEALTH TECHNOLOGIES LIMITEDEWO2025-11-19
B43071000030GoCheck MultiScreenerGobiquity, Inc.EWO2025-11-19
05711781004204Measure by OtometricsAuditdata A/SEWO2025-11-14
05711781004211Measure by OtometricsAuditdata A/SEWO2025-11-14
05711781004228Measure by OtometricsAuditdata A/SEWO2025-11-14
05711781004235Measure by OtometricsAuditdata A/SEWO2025-11-14
05711781004242Measure by OtometricsAuditdata A/SEWO2025-11-14
05711781004259Measure by OtometricsAuditdata A/SEWO2025-11-14
05711781004266Measure by OtometricsAuditdata A/SEWO2025-11-14
05711781004280Measure by OtometricsAuditdata A/SEWO2025-11-14
05711117230833Sanibel Supply A/SInteracoustics A/SEWO2025-08-07
05711117230840Sanibel Supply A/SInteracoustics A/SEWO2025-08-07
05711117230857Sanibel Supply A/SInteracoustics A/SEWO2025-08-07
05711117230864Sanibel Supply A/SInteracoustics A/SEWO2025-08-07
05711117245097Sanibel Supply A/SInteracoustics A/SEWO2025-08-07