FDA.reportPublic FDA data

Otoscan

Primary DI
05713315010699
Brand
Otoscan
Company
Natus Medical Denmark ApS
Model
043243
Catalog number
043243
Device description
1093,OTOSCAN Bundle – Scanner & Headset without laptop
Published
2023-05-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
05713315010699PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05713315010699057133150106995713315010699

GMDN Terms#

Term, Definition table
TermDefinition
Auditory canal scannerAn electrically-powered device intended to collect data for the creation of three-dimensional (3-D) models of the auditory canal (outer ear). It consists of a short tube for insertion into the auditory canal, a display screen to assist operation of the device, and connections to a computing device for power and data transfer. It has no therapeutic nor diagnostic functions and may be used in a non-clinical setting by a trained professional.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
306633756
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05713315000331GN Otometrics A/SHearing Instrument Programmer8-04-148002016-09-17
05713315012341Aurical Otocam 300-III10768-04-132602026-07-20
05713315006890Madsen Accsucreen8-04-139778-04-139772026-07-08
05713315006906Madsen Accuscreen8-04-139788-04-139782026-07-08
05713315008610Natus8-31-2008-31-2002020-12-16
05713315008627Natus8-31-190028-31-190022020-12-16
05713315000713GN Otometrics A/SPatient Responder (Red)8-31-1902016-09-19
057133150000581052 OTOsuite8-49-758008-49-758002026-06-22
057133150007511066 OTOsuite8-49-880008-49-880002026-06-22
057133150007681052 OTOsuite8-49-906008-49-906002026-06-22
05713315009051Natus8-62-453008-62-453002021-04-12
05713315008689Natus1053 Freefit Charger8-62-393032021-01-04
05713315005848GN Otometrics A/SProbe Tube Holder mk28-62-608002019-04-24
05713315000874GN Otometrics A/SOTOair Bluetooth Dongle8-62-415032016-09-19
05713315001055GN Otometrics A/SFreeFit REM probe8-69-392032016-09-19
05713315001192GN Otometrics A/SPMM RECD Probe Short8-69-392072016-09-19
05713315001208GN Otometrics A/SPMM RECD Probe Long8-69-392082016-09-19
05713315001215GN Otometrics A/SPMM RECD Probe Bin Long8-69-392092016-09-19
05713315001222GN Otometrics A/SPMM RECD Probe Bin Short8-69-392102016-09-19
05713315001246GN Otometrics A/SRECD Eartip Kit1-25-139042016-09-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260381960164LuxamedLuxamed GmbH & Co. KGERA2026-08-26
04260381960188LuxamedLuxamed GmbH & Co. KGERA2026-08-26
04260381960195LuxamedLuxamed GmbH & Co. KGERA2026-08-26
04260381960218LuxamedLuxamed GmbH & Co. KGERA2026-08-26
04260381963493LuxamedLuxamed GmbH & Co. KGERA2026-08-26
04260381963509LuxamedLuxamed GmbH & Co. KGERA2026-08-26
04260381964353LuxamedLuxamed GmbH & Co. KGERA2026-08-26
04260381964360LuxamedLuxamed GmbH & Co. KGERA2026-08-26
04260381964377LuxamedLuxamed GmbH & Co. KGERA2026-08-26
05713315012341Aurical Otocam 300-IIINatus Medical Denmark ApSERA2026-07-20
06972545090485JeashiaZhejiang Honsun Medical Technology Co., Ltd.ERA2026-07-17
16972545090154JeashiaZhejiang Honsun Medical Technology Co., Ltd.ERA2026-07-17
04260154547271OTOPRONTHappersberger Otopront GmbHERA2026-07-08
04260154547400OTOPRONTHappersberger Otopront GmbHERA2026-07-08
04260154547417OTOPRONTHappersberger Otopront GmbHERA2026-07-08
04260154547424OTOPRONTHappersberger Otopront GmbHERA2026-07-08
04260154547448OTOPRONTHappersberger Otopront GmbHERA2026-07-08
04260154547455OTOPRONTHappersberger Otopront GmbHERA2026-07-08
04260154547462OTOPRONTHappersberger Otopront GmbHERA2026-07-08
04260154547479OTOPRONTHappersberger Otopront GmbHERA2026-07-08
04260154547486OTOPRONTHappersberger Otopront GmbHERA2026-07-08
04260154547493OTOPRONTHappersberger Otopront GmbHERA2026-07-08
04260154547530OTOPRONTHappersberger Otopront GmbHERA2026-07-08
16972545090017JeashiaZhejiang Honsun Medical Technology Co., Ltd.ERA2026-05-18
16972545090031JeashiaZhejiang Honsun Medical Technology Co., Ltd.ERA2026-05-18
00050428029497CVSWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDERA2026-02-13
KTS0025716K.T.SurgicoK.T.SURGICOERA2024-07-24
00311917035000WalgreensWALGREEN CO.ERA2023-11-01
20884392954455Safety 1stDOREL JUVENILE GROUP, INC.ERA2023-10-15
10884389104514MedlineMEDLINE INDUSTRIES, INC.ERA2023-01-21