FDA.reportPublic FDA data

Eli Ezer

Primary DI
00851158007553
Brand
Eli Ezer
Company
U.S. OPHTHALMIC, L.L.C.
Model
EDC-2600
Device description
Screen Projector Ezer EDC-2600
Published
2018-10-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HOXChart, Visual Acuity

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HOXChart, Visual AcuityOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851158007553PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851158007553008511580075538511580075530851158007553

GMDN Terms#

Term, Definition table
TermDefinition
Vision testing/training chartAn ophthalmic chart or card printed with various symbols (e.g., letters, pictures or dots) intended to be used for testing visual acuity (e.g., Snellen chart) or testing and/or training accommodation and/or convergence or other amenable ophthalmic functions. The chart/card may be held in front of the patient or placed on a table or wall and may have specific user instructions depending on specific use. This is a reusable device.

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
06971922133319YEASNChongqing Yeasn Science & Technology Co.,Ltd.HOX2026-05-01
B43050085700GoCheck KidsGobiquity, Inc.HOX2026-01-09
04987669204610Open-field Refraction SystemNIDEK CO.,LTD.HOX2026-01-08
04987669204917Open-field Refraction SystemNIDEK CO.,LTD.HOX2026-01-08
04560126269287MIRROR CHART MC-5S for COMPU VISION CV-5000TOPCON CORPORATIONHOX2025-12-09
08800019601074Visual Acuity Chart System HDC-100Huvitz Co., Ltd.HOX2025-11-19
B43071000030GoCheck MultiScreenerGobiquity, Inc.HOX2025-11-19
B43050085610GoCheck KidsGobiquity, Inc.HOX2025-11-04
B43050085600GoCheck KidsGobiquity, Inc.HOX2025-10-22
04540008310580RexxamREXXAM CO., LTD.HOX2025-10-17
04540008310610RexxamREXXAM CO., LTD.HOX2025-10-17
00812559012003NearBrightREICHERT, INC.HOX2025-08-12
00812559012010NearBrightREICHERT, INC.HOX2025-08-12
00812559012201ClearChart4REICHERT, INC.HOX2025-08-12
00812559012225ClearChart4XREICHERT, INC.HOX2025-08-12
00812559012232ClearChart4PREICHERT, INC.HOX2025-08-12
B43050085500GoCheck KidsGobiquity, Inc.HOX2025-03-20
08034028770562TOPCONVISIA IMAGING SRLHOX2025-02-20
B43071000020GoCheck MultiScreenerGobiquity, Inc.HOX2024-09-23
06971922133234YEASNChongqing Yeasn Science & Technology Co.,Ltd.HOX2024-08-08
B43050085440GoCheck KidsGobiquity, Inc.HOX2024-07-26
B43071000010GoCheck KidsGobiquity, Inc.HOX2024-07-26
08800074500008Visual Chart SystemVIEW-M TECHNOLOGY CO., LTD.HOX2024-03-25
08800074500015Visual Chart SystemVIEW-M TECHNOLOGY CO., LTD.HOX2024-03-25
08800074500022Visual Chart SystemVIEW-M TECHNOLOGY CO., LTD.HOX2024-03-25
08800074500039Visual Chart SystemVIEW-M TECHNOLOGY CO., LTD.HOX2024-03-25
08800074500114Visual Chart SystemVIEW-M TECHNOLOGY CO., LTD.HOX2024-03-25
08800074500190Self Vision TesterVIEW-M TECHNOLOGY CO., LTD.HOX2024-03-25
08800074500213Self Vision TesterVIEW-M TECHNOLOGY CO., LTD.HOX2024-03-25
08800074500282Visual Chart SystemVIEW-M TECHNOLOGY CO., LTD.HOX2024-03-25