FDA.reportPublic FDA data

Eli Ezer

Primary DI
00851158007409
Brand
Eli Ezer
Company
U.S. OPHTHALMIC, L.L.C.
Model
EZ-OTC-1800/HL
Device description
Ezer Fiber Otoscope
Published
2016-09-28
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
00851158007409PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851158007409008511580074098511580074090851158007409

GMDN Terms#

Term, Definition table
TermDefinition
General physical examination setA collection of hand-held devices, battery-powered but may include manual, intended to be used by a physician to help perform parts of a general physical examination of a patient [i.e., ear/nose/throat (ENT) and ophthalmic examinations, blood pressure measurements, temperature] commonly conducted in a primary care setting. The devices (e.g., aneroid sphygmomanometer, otoscope, ophthalmoscope, electronic thermometer) are typically housed within a line-powered charging station (e.g., desktop, wall-mounted) or carry case, which may include accessories (e.g., ear specula, spare light bulbs). This is a reusable device that may contain some disposable devices.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
166760392
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
00850038195564EZ-TRI-3600EZ-TRI-36002025-02-19
00850038195557LuxVsionLDR-7800LDR-78002024-04-08
00851158007805Eli EzerEDR-H2024-04-08
00851158007836Eli EzerEDR-9000 A2024-04-08
00850038195335Eli EzerEZ-OPH-3600-Halogen-Lamp2024-04-03
00850038195342Eli EzerEZ-OPH-3600- Led Lamp2024-04-03
00851158007621Eli EzerESL-Emerald-12024-01-25
00851158007638Eli EzerESL-Emerald-82024-01-25
00851158007645Eli EzerESL-Emerald-182024-01-25
00851158007652Eli EzerESL-Emerald-122024-01-25
00851158007669Eli EzerESL-Emerald-262024-01-25
00851158007683Eli EzerESL-Emerald-TN2024-01-25
00851158007003LuxVisionSL-11002016-08-16
00851158007010LuxVisionSL-14002016-08-16
00851158007027LuxVisionSL-20002016-08-16
00851158007034LuxVisionSL-7002016-08-16
00851158007041LuxVisionSL-8802016-08-16
00851158007126GilrasGR-7/LL2016-08-17
00851158007133GilrasGR-7/HL2016-08-17
00851158007140GilrasGR-7 2X/HL2016-08-17

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