FDA.reportPublic FDA data

Video Otoscope

Primary DI
B809M300000003000
Brand
Video Otoscope
Company
orlvision GmbH
Model
OX2
Catalog number
M-300-00000-3000
Device description
Flexible Video Otoscope for examination of the outer ear
Published
2020-03-06
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
B809M300000003000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Otoscope, directA portable, battery-powered, hand-held device (non-endoscopic) primarily designed for examination of the outer ear canal and tympanic membrane (eardrum) by direct viewing through the ear opening. The device consists of a handle that contains the batteries (which may be rechargeable), a built-in light to illuminate the interior of the ear canal, and a detachable cone-shaped tube (the speculum) that is inserted in the ear canal. In some cases a moderate air pressure may be applied. Supplemental devices (e.g., additional specula, spare light bulbs) may be included. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
341467978
Device count
1
DM exempt
true
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B809M205240310101Flexible Video Rhino LaryngoscopeRSX-USBM-205-24031-01012020-03-06
B809M105220300700Laryngoskop FS212020-10-19
B809M205220310101Flexible Video Rhino LaryngoscopeRSX-PM-205-22031-01012020-03-06
B809M2052203101010LaryngoscopeRSX USB PM2052203101012019-11-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260381960164LuxamedLuxamed GmbH & Co. KGERA2026-08-26
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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