FDA.reportPublic FDA data

GN Otometrics A/S

Primary DI
05713315004070
Brand
GN Otometrics A/S
Company
Natus Medical Denmark ApS
Model
AURICAL
Catalog number
8-04-14533
Device description
1081 AURICAL AUD w/o HI-PRO (US only) Incl. Bone conductor/Insert Phone and TDH Headset
Published
2016-09-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EWOAudiometer

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05713315004070PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05713315004070057133150040705713315004070

GMDN Terms#

Term, Definition table
TermDefinition
Tone audiometer, semi-automatedAn electroacoustic device designed to measure the hearing threshold of a patient by presenting tones of increasing or decreasing intensity through headphones to establish the level at which the patient first becomes aware of the sounds. The device automatically produces tones that sweep the audiometric scale while the patient controls intensity, typically by pressing a button, when the tone cannot be heard. The device also records the patient's responses. This device may have the capacity to present a fixed frequency or a steadily changing frequency. It may also provide both continuous and pulsed tone outputs.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
306633756
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05713315008474Otometrics1085, FACE CUSHION 2 ASM KIT8-35-501002020-06-02
05713315008443Otometrics1085, STRAP ASSEMBLY8-35-342002019-11-20
05713315008467Otometrics1085, FACE PAD ASSEMBLY KIT V28-35-393002020-05-18
05713315003295OtometricsGoggle face cushion kit2019-04-24
05713315005268GN Otometrics A/S1085, GOGGLE HOME KIT2016-09-23
05713315002915GN Otometrics A/SDisposable Diff VEMP Electrode2019-04-01
05713315002649GN Otometrics A/S"Disposable Electrode 24"" Wired Qty 10"2016-09-26
05713315000874GN Otometrics A/SOTOair Bluetooth Dongle2016-09-19
05713315011597RetCam Envision61-00030061-0003002026-02-10
05713315011641RetCam EnvisionRETCAM-FA-UPGRADERETCAM-FA-UPGRADE2026-02-10
05713315011924RetCam Envision60-00007060-0000702026-02-10
05713315011931RetCam Envision60-00009060-0000902026-02-10
05713315011948RetCam Envision60-00009260-0000922026-02-10
05713315011962RetCam Envision61-00050061-0005002026-02-10
05713315012068Echo-Screen III0135700135702026-01-29
05713315012013Echo-Screen III0091490091492026-01-28
05713315012037Echo-Screen III0109990109992026-01-28
05713315012051Echo-Screen III0126250126252026-01-28
05713315011436ALGO Pro0361770361772026-01-23
05713315011443ALGO Pro0362440362442026-01-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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
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
04260223147449nanoAudio DD45 SetPATH medical GmbHEWO2025-08-05
04260223147456nanoAudio DD45 Set with Patient Response ButtonPATH medical GmbHEWO2025-08-05
04260223147463nanoAudio DD45 Set with Patient Response Button and Hughson-WestlakePATH medical GmbHEWO2025-08-05
04260223147470nanoAudio DD65v2 SetPATH medical GmbHEWO2025-08-05
04260223147487nanoAudio DD65v2 Set with Patient Response ButtonPATH medical GmbHEWO2025-08-05
04260223147494nanoAudio DD65v2 Set with Patient Response Button and Hughson-WestlakePATH medical GmbHEWO2025-08-05