FDA.reportPublic FDA data

LensHooke Cleaning Wipe

Primary DI
14719874740747
Brand
LensHooke Cleaning Wipe
Company
BONRAYBIO CO., LTD.
Model
Cleaning Wipe Package-10pcs-US
Catalog number
CW0
Published
2025-02-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
POVSemen Analysis Device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
POVSemen Analysis DeviceHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K202089000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202089000LensHooke X1 PRO Semen Quality Analyzer, LensHooke X1 PRO SE Semen Quality AnalyzerBonraybio Co., Ltd.2020-10-28POV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14719874740747PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1471987474074714719874740747

GMDN Terms#

Term, Definition table
TermDefinition
Dry medical towel/wipe, single-useA dry fabric intended to be used to wipe or dry a patient’s intact skin (not related to wound care), clean medical devices/equipment (e.g., endoscopes, ultrasound systems), and/or clean the general environment (e.g., fluid spill). It may be moistened (e.g., with water or used together with disinfectant/cleaning solutions) however no solutions are included. Some devices may be provided sterile, or designed to be sterilized, for use under sterile conditions [e.g., within an operating room (OR)]; devices intended for non-surgical applications may be provided and used in a non-sterile state. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
658872369
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
14719874742680LensHooke Semen Quality AnalyzerX3 PRO SEX3 PRO SE2026-04-23
14719874743502LensHooke Semen Test SlideCS3-01 Package-25pcs-US-HTCS3-01 10um2026-02-06
14719874743519LensHooke Semen Test SlideCS3-01 Package-25pcs-US-BRCS3-01 10um2026-02-06
14719874743526LensHooke Sperm Double Strand DNA fragmentation Rapid Test Kit (SDFR Assay)R11 Plus-01 Package-10 tests-US-BRR11 Plus-012026-02-06
14719874743533LensHooke Sperm Double Strand DNA Fragmentation Rapid Test Kit (SDFR assay)R11 Plus-01 Package-10 tests-US-HTR11 Plus-012026-02-06
14719874743564LensHooke Sperm DNA fragmentation rapid test kit (SCD assay)R10 Plus-01 Package-10 tests-US-BRR10 Plus-012026-02-06
14719874743571LensHooke Sperm DNA fragmentation rapid test kit (SCD assay)R10 Plus-01 Package-10 tests-US-HTR10 Plus-012026-02-06
14719874742796LensHooke Sperm DNA fragmentation rapid test kit (SCD assay)R10 Plus Package-10 tests-US-BRR10 Plus2025-02-16
14719874742802LensHooke Sperm DNA fragmentation rapid test kit (SCD assay)R10 Plus Package-10 tests-US-HTR10 Plus2025-02-16
14719874743458LensHooke Semen Analysis SystemX12 Package-1pcs-US HT(Plug UL)/RXX12 PRO2025-09-01
14719874743465LensHooke Semen Analysis SystemX12 Package-1pcs-US BR(Plug UL)/RXX12 PRO2025-09-01
24719874742267LensHooke Sperm Separation DeviceCA0 Package-150 sets-EN-CECA02025-04-10
14719874742222LensHooke Sperm Separation DeviceCA1 Package-25 sets-US-HTCA12025-02-16
14719874742239LensHooke Sperm Separation DeviceCA0 Package-25 sets-US-HTCA02025-02-16
14719874742253LensHooke Sperm Separation DeviceCA0 Package-25 sets-US-BRCA02025-02-16
14719874742284LensHooke Sperm Separation DeviceCA1 Package-25 sets-US-BRCA12025-02-16
24719874742250LensHooke Sperm Separation DeviceCA0 Package-150 sets-US-BRCA02025-02-16
24719874742236LensHooke Sperm Separation DeviceCA0 Package-150 sets-US-HTCA02025-02-16
04719874741242LensHooke Liquefaction EnzymeCK1 Package-10pcs-US HTCK12025-02-16
04719874741303LensHooke Semen Quality AnalyzerUL-US-X1.E206X1 PRO2025-02-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
14719874742680LensHooke Semen Quality AnalyzerBONRAYBIO CO., LTD.POV2026-04-23
00859500005288FemSperm Analyzer FEMASYS INC.POV2026-02-06
00859500005318FemSperm Pack AnalysisFEMASYS INC.POV2026-02-06
00859500005349FemSperm Pack AnalysisFEMASYS INC.POV2026-02-06
14719874743502LensHooke Semen Test SlideBONRAYBIO CO., LTD.POV2026-02-06
14719874743519LensHooke Semen Test SlideBONRAYBIO CO., LTD.POV2026-02-06
14719874743526LensHooke Sperm Double Strand DNA fragmentation Rapid Test Kit (SDFR Assay)BONRAYBIO CO., LTD.POV2026-02-06
14719874743533LensHooke Sperm Double Strand DNA Fragmentation Rapid Test Kit (SDFR assay)BONRAYBIO CO., LTD.POV2026-02-06
14719874743564LensHooke Sperm DNA fragmentation rapid test kit (SCD assay)BONRAYBIO CO., LTD.POV2026-02-06
14719874743571LensHooke Sperm DNA fragmentation rapid test kit (SCD assay)BONRAYBIO CO., LTD.POV2026-02-06
20888937025846HBA®Coopersurgical, Inc.POV2025-10-20
14719874743458LensHooke Semen Analysis SystemBONRAYBIO CO., LTD.POV2025-09-01
14719874743465LensHooke Semen Analysis SystemBONRAYBIO CO., LTD.POV2025-09-01
07290016650822SQA-iOw Sperm Quality AnalyzerM.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.POV2025-05-21
04719874741303LensHooke Semen Quality AnalyzerBONRAYBIO CO., LTD.POV2025-02-16
14719874740808LensHooke Cleaning WipeBONRAYBIO CO., LTD.POV2025-02-16
14719874743069LensHooke Cleaning WipeBONRAYBIO CO., LTD.POV2025-02-16
14719874743076LensHooke Cleaning WipeBONRAYBIO CO., LTD.POV2025-02-16
04719874741297LensHooke Semen Quality AnalyzerBONRAYBIO CO., LTD.POV2025-02-13
07290016650754YO Home Sperm TestM.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.POV2025-01-16
07290016650761YO Home Sperm TestM.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.POV2025-01-16
07290016650778YO Home Sperm TestM.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.POV2025-01-16
07290016650785YO Home Sperm TestM.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.POV2025-01-16
07290016650792YO Home Sperm TestM.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.POV2025-01-16
00843277100048SwimCount Sperm Quality TestMotilitycount ApSPOV2024-06-17
07290016650402SQA-iO Sperm Quality AnalyzerM.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.POV2023-09-06
07290016650587YO Home Sperm TestM.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.POV2023-01-01
00860001286533Men's Rapid Fertility TestMEDTOX DIAGNOSTICS, INC.POV2022-07-26
00862105000398TrakMEDTOX DIAGNOSTICS, INC.POV2022-07-05
00862105000305Men's Rapid Fertility TestMEDTOX DIAGNOSTICS, INC.POV2022-06-13