FDA.reportPublic FDA data

1077 EARTIP 12-16 BLUE 100 PCS

Primary DI
04260223145346
Brand
1077 EARTIP 12-16 BLUE 100 PCS
Company
PATH medical GmbH
Model
8-68-34507
Published
2020-06-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
ETTCushion, Earphone (For Audiometric Testing)
GWJStimulator, Auditory, Evoked Response

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ETTCushion, Earphone (For Audiometric Testing)Ear, Nose, Throat1
GWJStimulator, Auditory, Evoked ResponseNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260223145346PrimaryGS10
04260223140600Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260223145346042602231453464260223145346
04260223140600042602231406004260223140600

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
551540334
Device count
100
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260223145995Ear Coupler Set100890-302026-07-24
04260223147579Infant Insert Eartips 4.0mm (bag of 20)100905-P-202026-07-24
04260223147586Infant Insert Eartips 3.5mm (bag of 20)100906-P-202026-07-24
04260223147654Bone Conductor BC-2LD1014752026-07-24
04260223147661Bone Conductor BC-2LD1014762026-07-24
04260223147678Bone Conductor BC-2LD1014772026-07-24
04260223147746Ear Coupler TR1015062026-07-24
04260223147975PIEP (2x2)1013442026-07-24
04260223148002Accessory box AB-LT021013402026-07-24
04260223147326nanoAudio DD45101414-012025-08-05
04260223147333nanoAudio DD65v2101414-022025-08-05
04260223147340nanoAudio Patient Response Button1014202025-08-05
04260223147418Sentiero Screening 3100098-S32025-08-05
04260223147449nanoAudio DD45 Set101470-012025-08-05
04260223147456nanoAudio DD45 Set with Patient Response Button101470-022025-08-05
04260223147463nanoAudio DD45 Set with Patient Response Button and Hughson-Westlake101470-032025-08-05
04260223147470nanoAudio DD65v2 Set101470-042025-08-05
04260223147487nanoAudio DD65v2 Set with Patient Response Button101470-052025-08-05
04260223147494nanoAudio DD65v2 Set with Patient Response Button and Hughson-Westlake101470-062025-08-05
04260223147630Sentiero Screening3 DPOAE Set100250-SC3-D-LT2025-08-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260223145995Ear Coupler SetPATH medical GmbHGWJ2026-07-24
04260223147579Infant Insert Eartips 4.0mm (bag of 20)PATH medical GmbHETT2026-07-24
04260223147579Infant Insert Eartips 4.0mm (bag of 20)PATH medical GmbHGWJ2026-07-24
04260223147586Infant Insert Eartips 3.5mm (bag of 20)PATH medical GmbHETT2026-07-24
04260223147586Infant Insert Eartips 3.5mm (bag of 20)PATH medical GmbHGWJ2026-07-24
04260223147654Bone Conductor BC-2LDPATH medical GmbHGWJ2026-07-24
04260223147661Bone Conductor BC-2LDPATH medical GmbHGWJ2026-07-24
04260223147678Bone Conductor BC-2LDPATH medical GmbHGWJ2026-07-24
04260223147746Ear Coupler TRPATH medical GmbHGWJ2026-07-24
04260223147975PIEP (2x2)PATH medical GmbHGWJ2026-07-24
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
00817020020723Screener CartINTELLIGENT HEARING SYSTEMS CORP.GWJ2026-06-10
00817020020990Trigger Out Cable for USB Jr DuetINTELLIGENT HEARING SYSTEMS CORP.GWJ2026-06-10
00817020021140Diagnostic CartINTELLIGENT HEARING SYSTEMS CORP.GWJ2026-06-10
B43061000100GoCheck Audiometric Headphone AssemblyGobiquity, Inc.ETT2026-06-02
B592SW100WAVi Scan SoftwareWAVI CO.GWJ2026-03-25
B592WD100WAVi Electrical Processing UnitWAVI CO.GWJ2026-03-25
B592WK200WAVi Scan KitWAVI CO.GWJ2026-03-25
08056446901106NExT-DOCKINGEB NEURO SPAGWJ2025-05-22
08056446901113NExT-PADEB NEURO SPAGWJ2025-05-22
08056446901120NExT-AMP-ADVANCEDEB NEURO SPAGWJ2025-05-22
08056446901137NExT-HSEB NEURO SPAGWJ2025-05-22
08056446901168NExT-AMPEB NEURO SPAGWJ2025-05-22
08056446901199NExT-ASEB NEURO SPAGWJ2025-05-22
08056446901205NExT StationEB NEURO SPAGWJ2025-05-22
08056446901090NExT Station AdvancedEB NEURO SPAGWJ2025-05-19