FDA.reportPublic FDA data

OTOSCOPE

Primary DI
B366OT101
Brand
OTOSCOPE
Company
Ecleris
Model
R00
Catalog number
OT101
Device description
Otoscope, 2,7mm Ø, 0°, 75mm L
Published
2022-11-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
B366OT101PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Otoscope, endoscopicAn endoscope with a rigid inserted portion intended to be used in otology mainly for observation, diagnosis, and treatment of the outer and/or middle ear. Anatomical images are transmitted to the user by the device through relayed lens optics or a fibreoptic bundle typically with images displayed on a monitor. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity5 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity5 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-40 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
786-483-7490ytzielo@ecleris.com

Regulatory Flags#

DUNS number
043555079
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B366U1VI360R04Procam HD CMOS IIR04U1VI3602026-05-27
B366U1VI3605PROCAM 4K USBRX1VI360/52026-05-19
B366LED0204R00PORTALEDR00LED020/42026-02-11
B366U1C200FR01MICROSCOPE ColposcopeR01U1C200F2024-02-13
B366U1C200TR01MICROSCOPE ColposcopeR01U1C200T2024-02-13
B366U1C200WR01MICROSCOPE ColposcopeR01U1C200W2024-02-13
B366HC200AR00MICROSCOPE ColposcopeR00HC200A2024-11-27
B366U1C200AR00MICROSCOPE ColposcopeR00U1C200A2024-11-25
B366U1C200FR00MICROSCOPE ColposcopeR00U1C200F2024-02-07
B366U1C200TR00MICROSCOPE ColposcopeR00U1C200T2024-02-07
B366U1C200WR00MICROSCOPE ColposcopeR00U1C200W2024-02-07
B366MC400MICROSTAR ColposcopeR02MC4002023-08-22
B366MC410MICROSTAR ColposcopeR00MC4102023-08-22
B366C100FHD1MICROSTAR ColposcopeR00C100FHD12023-08-18
B366SN0300140SinuscopeR00SN03001402023-08-18
B366SN0330140SinuscopeR00SN03301402023-08-18
B366SN0370140SinuscopeR00SN03701402023-08-18
B366SN0400175SinuscopeR00SN04001752023-08-18
B366SN0430175SinuscopeR00SN04301752023-08-18
B366SN0445175SinuscopeR00SN04451752023-08-18

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