FDA.report

GN Otometrics A/S

Primary DI
05713315001307
Brand
GN Otometrics A/S
Company
Gn Otometrics A/S
Model
MADSEN Capella2, DP+TE (combo)
Published
2016-09-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
EWOAudiometer

Product Code Classifications

CodeDeviceSpecialtyClass
EWOAudiometerEar, Nose, Throat2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05713315001307PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05713315001307057133150013075713315001307

GMDN Terms

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

Regulatory Flags

DUNS number
306633756
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
057133150107361091, ICS Dizcovery System8-04-164008-04-164002025-02-21
057133150108111091, ICS Dizcovery ShadeShift Panels 0456540456542025-02-21
057133150108281091, ICS Dizcovery LCD Panels0456520456522025-02-21
057133150108801091, ICS Dizcovery Universal Face Cushion (qty 40)0456570456572025-02-21
05713315007415MADSEN Astera 28-04-131278-04-131272024-12-12
05713315007439MADSEN Astera 28-04-131288-04-131282024-12-12
05713315007477MADSEN Astera 28-04-121188-04-121182024-12-12
05713315007521MADSEN Astera 28-04-131248-04-131242024-12-12
05713315007859MADSEN Astera 28-04-131048-04-131042024-12-12
05713315007132GN Otometrics A/SICS Impulse2024-12-04
05713315011054Otoscan0432440432442024-04-15
05713315008726Disposable Snap Electrodes (3 pack)8-64-210008-64-210002022-12-14
05713315008733Disposable Snap Electrodes (25 x 3 pack)8-64-218008-64-218002022-12-14
05713315010279Madsen A4508-04-14660 8-04-14660 2022-12-28
05713315010286Madsen A4508-04-14661 8-04-14661 2022-12-28
05713315010293Madsen A4508-04-14662 8-04-14662 2022-12-28
05713315009464Madsen Zodiac8-04-163078-04-163072022-12-05
05713315010699Otoscan0432430432432023-05-11
05713315009969Bone Conductor (BC-2)0415450415452023-03-09
05713315010101Bone Conductor (BC-2)0415460415462023-03-09

Other Devices Sharing Product Codes

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