FDA.reportPublic FDA data

IEC-Innoview GmbH

Primary DI
B192300043000
Brand
IEC-Innoview GmbH
Company
INNOVATIVE ENDOSCOPY COMPONENTS, L.L.C.
Model
30-0043-00
Catalog number
30-0043-00
Device description
4.0 mm, 0 deg. Otoscope, l=50mm, autoclavable
Published
2016-05-24
Public version status
Update
Distribution status
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
B192300043000PrimaryHIBCC0

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Angle0degree
Length50Millimeter
Outer Diameter4Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
010741028
Device count
1
DM exempt
true
Premarket exempt
true
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B192300003000IEC-Innoview GmbH30-0003-0030-0003-002016-05-31
B192300004000IEC-Innoview GmbH30-0004-0030-0004-002016-05-23
B192300006000IEC-Innoview GmbH30-0006-0030-0006-002016-05-23
B192300008000IEC-Innoview GmbH30-0008-0030-0008-002016-05-23
B192300010000IEC-Innoview GmbH30-0010-0030-0010-002016-05-23
B192300011000IEC-Innoview GmbH30-0011-0030-0011-002016-05-24
B192300012000IEC-Innoview GmbH30-0012-0030-0012-002016-05-24
B192300054000IEC-Innoview GmbH30-0054-0030-0054-002016-06-02
B192300055000IEC-Innoview GmbH30-0055-0030-0055-002016-05-24
B192300057000IEC-Innoview GmbH30-0057-0030-0057-002016-05-24
B192300068000IEC-Innoview GmbH30-0068-0030-0068-002016-07-12
B192300311000IEC-Innoview GmbH30-0311-0030-0311-002016-05-24
B192300346000IEC-Innoview GmbH30-0346-0030-0346-002016-05-24
B192300348000IEC-Innoview GmbH30-0348-0030-0348-002016-05-24
B192300421000IEC-Innoview GmbH30-0421-0030-0421-002016-05-24
B192300514000IEC-Innoview GmbH30-0514-0030-0514-002016-05-26
B192300515000IEC-Innoview GmbH30-0515-0030-0515-002016-05-26
B192300646000IEC-Innoview GmbH30-0646-0030-0646-002016-07-12
B1921091313550Eberle10-91313-5510-91313-552023-06-08
B192300048000IEC-Innoview GmbH30-0048-0030-0048-002023-06-08

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Primary DI, Brand, Company table
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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
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04260154547530OTOPRONTHappersberger Otopront GmbHERA2026-07-08
16972545090017JeashiaZhejiang Honsun Medical Technology Co., Ltd.ERA2026-05-18
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KTS0025716K.T.SurgicoK.T.SURGICOERA2024-07-24
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