FDA.reportPublic FDA data

Bio-logic

Primary DI
00382830052283
Brand
Bio-logic
Company
NATUS MEDICAL INCORPORATED
Model
Sinser Tip White
Catalog number
202160
Device description
Replacement Sinser Tips, white, for use with 580-SINSER insert earphones
Published
2017-04-03
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
K031009000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K031009000MODIFICATION TO BIO-LOGIC EVOKED POTENTIAL (EP) SYSTEMBio-Logic Systems Corp.2003-04-28GWJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00382830052283PrimaryGS10
00382830054300Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00382830052283003828300522833828300522830382830052283
00382830054300003828300543003828300543000382830054300

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

Contacts#

Phone, Email table
PhoneEmail
1-800-303-0306BLSC_Hearing_Support@natus.com

Regulatory Flags#

DUNS number
962519208
Device count
10
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00382830008365Bio-logicDisposable Snap Electrodes101600; 1016032016-12-30
00382830045247Echo-Screen III ProEchoScreen III Refurbished, TEOAE with barcode023480R2020-02-20
00382830045278Echo-Screen III ProEchoScreen III Refurbished, DPOAE with barcode023481R2020-02-20
00382830045292Echo-Screen III ProEchoScreen III Refurbished, ABR with barcode023482R2020-02-20
00382830045315Echo-Screen III ProEchoScreen III Refurbished, TEOAE & DPOAE with bar023483R2020-02-20
00382830045339Echo-Screen III ProEchoScreen III Refurbished, TEOAE & ABR with barco023484R2020-02-20
00382830045353Echo-Screen III ProEchoScreen III Refurbished, DPOAE & ABR with barco023485R2020-02-20
00382830000727NATUS MEDICAL2032002016-10-26
00382830000734Bio-logicOAE Foam Tip Pediatric203201, 294252016-12-30
00382830000741Bio-logicOAE Foam Tip Adult203202, 294272017-03-31
00382830000758Bio-logicOAE Tree Tip203208, 294212017-03-31
00382830000765Bio-logicOAE Tree Tip Preemie2032092017-03-31
00382830000772Bio-logicOAE Jumbo Tip2032102017-03-31
00382830000789Bio-logicOAE Foam Tip Pediatric203211, 294262016-12-30
00382830000796Bio-logicOAE Foam Tip Adult203212, 294282017-03-31
00382830000819Bio-logicOAE Tree Tip203218, 294222017-03-31
00382830000826Bio-logicOAE Tree Tip Preemie2032192017-03-31
00382830000833Bio-logicOAE 6mm Tip203333, 294232016-12-30
00382830000840Bio-logicOAE 6mm Tip203353, 294242016-12-30
00382830000871Natus Silver Disc Electrode Silicone1010012017-05-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810046707562Grason-StadlerDiagnostic Group LLCEWO2026-06-04
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