LensHooke semen Test Cassette

GUDID 54719874741155

BONRAYBIO CO., LTD.

Microscope counting chamber IVD

• Primary Device ID: 54719874741155
• NIH Device Record Key: e8c374f5-0a78-428c-8de0-027343cd08cb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LensHooke semen Test Cassette
• Version Model Number: CS1_400pcs_HT
• Company DUNS: 658872369
• Company Name: BONRAYBIO CO., LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	54719874741155 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202089

FDA Product Code

• POV: Semen Analysis Device

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-07-19
• Device Publish Date: 2021-07-09

On-Brand Devices [LensHooke semen Test Cassette]

• 14719874741157: CS1_US-HT
• 14719874741140: CS1_US-BR USA
• 54719874741155: CS1_400pcs_HT
• 54719874741148: CS1_400pcs_BR USA CORP.
• 54719874740769: CS0_400pcs_BR USA CORP.
• 54719874740714: CS0_400pcs
• 44719874741158: CS1_200pcs_HT
• 44719874741141: CS1_200pcs_BR USA CORP.
• 44719874740762: CS0_200pcs_BR USA CORP.
• 44719874740717: CS0_200pcs