FDA.reportPublic FDA data

Eye chart, pictures for children according to Löhlein

Primary DI
04049584006486
Brand
Eye chart, pictures for children according to Löhlein
Company
OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung
Model
46936
Device description
Eye chart, pictures for children according to Löhlein
Published
2022-12-07
Public version status
New
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
04049584006486PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049584006486040495840064864049584006486

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius55 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
317138956
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04049584034953Pentacam Cornea OCT100190012026-03-31
04049584037909Cable SDI BIOM 6 for Alcon LuxOR Revalia100401382026-02-11
04049584037916Cable Y BIOM 6 for Haag Streit Metis 900100401372026-02-11
04049584037930Cable CAN BIOM 6 for Leica Proveo 8 / 8x100413192026-02-11
04049584037954Cable CTRL BIOM 6 for Leica Proveo 8 / 8x100432282026-02-11
04049584037961Cable Y BIOM 6 for Alcon LuxORRevalia100425572026-02-11
04049584038012Cable CAN BIOM 6 for B&L SeeLuma100428332026-02-11
04049584037695Focusing Module BIOM 6, 175 mm100351102026-01-23
04049584037701Focusing Module BIOM 6, 200 mm100379072026-01-23
04049584037718Precision Mount for B&L100394002026-01-23
04049584037725Precision Mount for Leica100390582026-01-23
04049584037732Precision Mount for Alcon100291772026-01-23
04049584037749Precision Mount for Zeiss100392342026-01-23
04049584037756Precision Mount for Haag Streit100291782026-01-23
04049584035714BIOM 6 HD Optic Set for f=175 mm100299002026-01-14
04049584035721BIOM 6 HD Optic Set for f=200 mm100299022026-01-14
04049584035738BIOM 6 HD Optic Set for f=175 mm100299002026-01-14
04049584035745BIOM 6 HD Optic Set for f=200 mm100299022026-01-14
04049584037152BIOM 6100348202026-01-14
04049584037251Twinfield 3100348192026-01-14

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