FDA.reportPublic FDA data

Resonance

Primary DI
08051597160297
Brand
Resonance
Company
M.R.S. SRL
Model
RE-VO2 BULK
Catalog number
4300103530
Device description
USB VIDEO OTOSCOPE BULK PACKAGE
Published
2025-09-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
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
08051597160297PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08051597160297080515971602978051597160297

GMDN Terms#

Term, Definition table
TermDefinition
Video otoscope/audiometerAn electrically-powered portable device intended for the visual examination of the outer ear canal/tympanic membrane by video otology, and basic evaluation of hearing function. It consists of a speculum with integrated video camera, light source, pitch generator (speaker), and a dedicated smartphone for image display and data relay to a central datastore; it may provide a conduit for a microsuction device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
514071869
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08051597160501ResonanceRE-VO243001035202025-09-03
08051597160549ResonanceRE-VO2 + CRADLE43001035402025-09-03
08051597160051ResonanceR15C43001043002025-09-01
08051597160099ResonanceR16M43001041002025-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10884389104521MedlineMEDLINE INDUSTRIES, INC.ERA2023-01-21
17290018446154Nonagon N9+NONAGON LTDERA2022-09-28
27290018446151Nonagon N9+ SmartExamNONAGON LTDERA2022-09-28
00860003469828hearXHEARX GROUP (PTY) LTDERA2022-05-30
M368122711LABTRONGF HEALTH PRODUCTS, INC.ERA2020-09-15
H65811255271Henry ScheinHENRY SCHEIN, INC.ERA2020-06-16
H65811255281Henry ScheinHENRY SCHEIN, INC.ERA2020-06-16
10304040029203Henry ScheinHENRY SCHEIN, INC.ERA2018-12-21
10304040029197Henry ScheinHENRY SCHEIN, INC.ERA2018-09-24