FDA.reportPublic FDA data

ILO

Primary DI
04250369709038
Brand
ILO
Company
ILO electronic GmbH
Model
Nex-Gen-HDoto
Catalog number
864-1002
Device description
FullHD Video-Otoscope
Published
2023-06-22
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
04250369709038PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250369709038042503697090384250369709038

GMDN Terms#

Term, Definition table
TermDefinition
Otoscope, directAn electrically-powered, hand-held device designed for examination of the outer ear canal and tympanic membrane (eardrum) by direct viewing through the ear opening. It consists of a main unit (commonly referred to as the head) with a built-in light source intended to illuminate the interior of the ear canal with a detachable cone-shaped tube (speculum) inserted in the ear canal; it may facilitate the application of air pressure for pneumatic otoscopy. A dedicated power supply handpiece and/or an insufflation bulb may be included with the head.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+49410677580info@ilo.com

Regulatory Flags#

DUNS number
341983849
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04250369709304ILOLED50-HD II862-25112024-09-09
04250369709762ILOLED50-HD II RW US862-25192024-09-09
04250369708161ILOLED 50-HD862-22512023-06-22
04250369708178ILOLED 50-HD-USB862-22012023-06-22
04250369709021ILOLED50-EcoHD II862-25012023-06-22
04250369709755ILOCamera head LED50-HDII740-20202024-09-09
04250369709779ILOCamera head LED50-HDII740-20212024-09-09
04250369706051ILOM-CAM 1HD USB853-02022023-06-22
04250369706099ILOSwift 1HD USB853-02012023-06-22
04250369706273ILOM-CAM 1HD853-00012023-06-22
04250369706655ILOTRIstar 4K USB854-00302023-06-22
04250369706709ILOTRIstar 4K854-00292023-06-22
04250369706716ILOM-CAM 4K854-00312023-06-22
04250369706723ILOM-CAM 4K USB854-00322023-06-22
04250369706747ILOLED 2500825-02012023-06-22
04250369706754ILOM-LED 2500825-02022023-06-22
04250369706761ILOLED 3000plus825-03012023-06-22
04250369706778ILOLED 3000Tplus825-03032023-06-22
04250369706785ILOM-LED 3000plus825-03022023-06-22
04250369706792ILOM-LED 3000Tplus825-03042023-06-22

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