FDA.report

GN Otometrics A/S

Primary DI
05713315002151
Brand
GN Otometrics A/S
Company
Gn Otometrics A/S
Model
1022, EAR TIP KIT,14 MM 50PCS
Published
2016-09-19
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
EWOAudiometer

Product Code Classifications

CodeDeviceSpecialtyClass
EWOAudiometerEar, Nose, Throat2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05713315002151PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05713315002151057133150021515713315002151

GMDN Terms

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

Regulatory Flags

DUNS number
306633756
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
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

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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

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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
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