FDA.reportPublic FDA data

Clement Clarke Ophthalmic

Primary DI
05056158000664
Brand
Clement Clarke Ophthalmic
Company
HAAG-STREIT UK LIMITED
Model
7004001
Catalog number
7004001
Device description
FIXATION BAR / BUDGY STICK
Published
2022-11-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
05056158000664PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05056158000664050561580006645056158000664

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

Contacts#

Phone, Email table
PhoneEmail
+441279414969thomas.whay@haag-streit.com

Regulatory Flags#

DUNS number
504108242
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
05056158000718Haag-Streit UK730900373090032022-11-23
05056158001807Haag-Streit UK730900173090012022-11-23
05056158001814Haag-Streit UK730900273090022022-11-23
05055296017497Haag Streit John Weiss010707301070732022-11-22
05060179470023Clement Clarke Ophthalmic6401001ULUS6401001ULUS2016-07-22
05060179470030Clement Clarke Ophthalmic6402001ULUS6402001ULUS2016-07-22
05060179470078Clement Clarke Ophthalmic580500158050012016-07-22
05060179470146Clement Clarke Ophthalmic6403001ULUS6403001ULUS2016-07-22
05060179470276Clement Clarke Ophthalmic5606011 US5606011 US2016-07-22
05060179470313Clement Clarke Ophthalmic5606013 US5606013 US2016-07-22
05060179470344Clement Clarke Ophthalmic6908000US6908000US2016-07-22
05060179470375Clement Clarke Ophthalmic700600170060012016-08-05
05060179470399Clement Clarke Ophthalmic700500170050012016-08-12
05060179470559Haag Streit UK580510058051002016-07-22
05060179470726Haag Streit UK470100147010012016-07-22
05056158000817Haag-Streit UK730900373090032022-11-23
05056158000220Haag-Streit UK730900173090012022-11-23
05056158000701Haag-Streit UK730900273090022022-11-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06971922133319YEASNChongqing Yeasn Science & Technology Co.,Ltd.HOX2026-05-01
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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