FDA.reportPublic FDA data

GN Otometrics A/S

Primary DI
05713315000041
Brand
GN Otometrics A/S
Company
Gn Otometrics A/S
Model
Otocam 300
Published
2016-09-17
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

Product Codes#

Code, Name table
CodeName
ERAOtoscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ERAOtoscopeEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05713315000041PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05713315000041057133150000415713315000041

GMDN Terms#

Term, Definition table
TermDefinition
Audiometer/otoscopeA battery-powered, hand-held device intended for: 1) visual examination of the outer ear canal and tympanic membrane (eardrum) by direct viewing through the ear opening; and 2) evaluation of hearing by generating tones throughout the audible range (usually at each octave between 125 Hz and 8 kHz) at amplitudes related to the expected thresholds for a normally hearing person, and presenting them to a patient (pure-tone audiometery). It consists of a handle that contains the batteries (which may be rechargeable), a built-in light to illuminate the ear canal, a pitch generator (speaker), and is intended to be used with a detachable ear speculum which may be included. This is a reusable device.

Sterilization Methods#

Method table
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
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 DI, Brand, Model table
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 DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00732094055245Welch Allyn, Inc.WELCH ALLYN, INC.ERA2026-03-06
40050428029495CVSWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDERA2026-02-13
06972545090416JeashiaZhejiang Honsun Medical Technology Co., Ltd.ERA2026-02-04
16972545090093JeashiaZhejiang Honsun Medical Technology Co., Ltd.ERA2026-02-04
06974546524372TealmedNingbo Tealmed Emergency Products Co., Ltd.ERA2026-01-16
00850042909218ProsidioProsidio LLCERA2025-12-05
00850042909225ProsidioProsidio LLCERA2025-12-05
00850042909256ProsidioProsidio LLCERA2025-12-05
00850042909263ProsidioProsidio LLCERA2025-12-05
00850042909270ProsidioProsidio LLCERA2025-12-05
00850042909287ProsidioProsidio LLCERA2025-12-05
00850042909294ProsidioProsidio LLCERA2025-12-05
00850042909300ProsidioProsidio LLCERA2025-12-05
00850042909317ProsidioProsidio LLCERA2025-12-05
00850042909324ProsidioProsidio LLCERA2025-12-05
00850042909331ProsidioProsidio LLCERA2025-12-05
00850042909348ProsidioProsidio LLCERA2025-12-05
00850042909355ProsidioProsidio LLCERA2025-12-05
00850042909362ProsidioProsidio LLCERA2025-12-05
00850042909379ProsidioProsidio LLCERA2025-12-05
00850042909386ProsidioProsidio LLCERA2025-12-05
00850042909393ProsidioProsidio LLCERA2025-12-05
00850042909409ProsidioProsidio LLCERA2025-12-05
00850042909416ProsidioProsidio LLCERA2025-12-05
00850042909423ProsidioProsidio LLCERA2025-12-05
00850042909430ProsidioProsidio LLCERA2025-12-05
00850042909447ProsidioProsidio LLCERA2025-12-05
00850042909454ProsidioProsidio LLCERA2025-12-05
00850042909461ProsidioProsidio LLCERA2025-12-05
00850042909478ProsidioProsidio LLCERA2025-12-05