FDA.reportPublic FDA data

Sanibel Supply A/S

Primary DI
05711117230840
Brand
Sanibel Supply A/S
Company
Interacoustics A/S
Model
ER10C-04
Catalog number
8537239
Published
2025-08-07
Public version status
New
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
EWOAudiometer

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K930553000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K930553000CUB DIS OTOACOUSTIC EMISSIONS TEST INSTRUMENTEtymotic Research1993-09-29EWO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05711117230840PrimaryGS10
05711117245103Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05711117230840057111172308405711117230840
05711117245103057111172451035711117245103

GMDN Terms#

Term, Definition table
TermDefinition
Audiometric ear tipA luminal device intended to be connected to the distal end of an audiometric sound delivery tube and inserted into the ear canal, to allow test sounds to be delivered to the ear in isolation from background noise. It is designed to create a seal inside the ear canal whilst allowing the sound tube to pass through the lumen. This is a single-use device.

Regulatory Flags#

DUNS number
306308354
Device count
20
Lot or batch
true
Manufacturing date on label
true
Donation ID number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05711117230796Sanibel Supply A/SSanibel EARturtle Universal85372062026-05-14
05711117230802Sanibel Supply A/SSanibel EARturtle Universal Box of 36 kits w/tab e85372092026-05-14
05711117244304Sanibel Supply A/SSanibel EARturtle Universal Box of 36 kits w/snap 86025002026-05-14
05711117244991InteracousticsVisualEyes 5052025-08-14
05711117245004InteracousticsVisualEyes EyeSeeCam vHIT2025-08-14
05711117245028InteracousticsVisualEyes 5252025-08-14
05711117230833Sanibel Supply A/SER10C-0385372382025-08-07
05711117230857Sanibel Supply A/SER10C-0585372402025-08-07
05711117230864Sanibel Supply A/SER10C-0685372412025-08-07
05711117245097Sanibel Supply A/SER10C-0385372382025-08-07
05711117245103Sanibel Supply A/SER10C-0485372392025-08-07
05711117245110Sanibel Supply A/SER10C-0585372402025-08-07
05711117245127Sanibel Supply A/SER10C-0685372412025-08-07
05711117008395Sanibel SupplyEar tip, OAE-4 ER Infant, 4 mm red flanged2022-12-08
05711117226089Sanibel SupplyEar tip infant 4 mm, ANA-4.0, blue2022-12-08
05711117226096Sanibel SupplyEar tip infant 5 mm, ANA-5.0, green2022-12-08
05711117226102Sanibel SupplyEar tip infant 4,5 mm, ANA-4.5, red-brown2022-12-08
05711117226119Sanibel SupplyEar tip 5 mm, AOT-5.0 light blue2022-12-08
05711117226126Sanibel SupplyEar tip 4 mm, AOT-4.0 green2022-12-08
05711117226133Sanibel SupplyEar tip 4-7 mm, AOT 4-7 transparent2022-12-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
05711117230857Sanibel Supply A/SInteracoustics A/SEWO2025-08-07
05711117230864Sanibel Supply A/SInteracoustics A/SEWO2025-08-07
05711117245097Sanibel Supply A/SInteracoustics A/SEWO2025-08-07
05711117245103Sanibel Supply A/SInteracoustics A/SEWO2025-08-07
05711117245110Sanibel Supply A/SInteracoustics A/SEWO2025-08-07
05711117245127Sanibel Supply A/SInteracoustics A/SEWO2025-08-07
04260223147326nanoAudio DD45PATH medical GmbHEWO2025-08-05
04260223147333nanoAudio DD65v2PATH medical GmbHEWO2025-08-05
04260223147340nanoAudio Patient Response ButtonPATH medical GmbHEWO2025-08-05
04260223147418Sentiero Screening 3PATH medical GmbHEWO2025-08-05