FDA.reportPublic FDA data

Etymotic Research

Primary DI
00846430004818
Brand
Etymotic Research
Company
ETYMOTIC RESEARCH, INC.
Model
ER3-04B
Device description
Gold plated brass tube nipples
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
GXYElectrode, Cutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXYElectrode, CutaneousNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K873298000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K873298000ELEC-TIPEtymotic Research1987-11-24GXY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00846430004818PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00846430004818008464300048188464300048180846430004818

GMDN Terms#

Term, Definition table
TermDefinition
Auditory stimulatorA mains electricity (AC-powered) device that applies sound stimuli (e.g., pure tones, speech) to a patient's acoustic system. It is typically used as a component of several types of devices such as audiometers, auditory evoked-potential recording systems, and auditory function screening devices.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
115380859
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00846430004443N/AER3-14B2016-09-19
00846430005426Etymotic ResearchER3-19-S12023-04-04
00846430005600EtymoticER3-14B-5002023-04-04
00846430005617EtymoticER3-14C-5002023-04-04
00846430005457EtymoticER3-192022-11-14
00846430005563EtymoticER13-14C2022-11-10
00846430005440N/AER3C-300 System2022-02-07
00846430005488N/AER3C-3002022-02-04
00846430005334Etymotic ResearchER3C-842022-01-26
00846430004078Single Use EartipER10D-T032016-09-20
00846430004085Single Use EartipER10D-T042016-09-19
00846430004092Single Use EartipER10D-T052016-09-20
00846430004108Single Use EartipER10-T062016-09-19
00846430004115Single Use EartipER10D-T072016-09-20
00846430004122Single Use EartipER10D-T082016-09-20
00846430004139Single Use EartipER10D-T092016-09-19
00846430004146Single Use EartipsER10D-T102016-09-19
00846430004153Single Use EartipER10D-T112016-09-20
00846430004160Single Use EartipER10D-T122016-09-20
00846430004177Single Use EartipER10D-T132016-09-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08682250582004Elde MedicalELDE MEDIKAL SANAYI VE TICARET ANONIM SIRKETIGXY2026-07-08
08682250582011Elde MedicalELDE MEDIKAL SANAYI VE TICARET ANONIM SIRKETIGXY2026-07-08
08720791378172Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378189Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378196Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378202Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378219Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378226Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378233Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378240Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378257Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378264Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378271Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378288Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378295Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378301Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378318Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378325Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378332Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378349Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378356Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378363Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378370Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378387Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378394Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378400Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378417Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378424Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378431Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378448Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08