LensHooke Sperm Separation Device CA0

GUDID 14719874742239

BONRAYBIO CO., LTD.

Sperm filtration system

• Primary Device ID: 14719874742239
• NIH Device Record Key: d731d3d5-4752-4ddb-9cb4-d69b65c752a6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LensHooke Sperm Separation Device
• Version Model Number: CA0 Package-25 sets-US-HT
• Catalog Number: CA0
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	14719874742239 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221810

FDA Product Code

• MQK: Labware, Assisted Reproduction

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-02-24
• Device Publish Date: 2025-02-16

On-Brand Devices [LensHooke Sperm Separation Device]

• 24719874742281: CA1 Package-150 sets-US-BR
• 24719874742250: CA0 Package-150 sets-US-BR
• 24719874742236: CA0 Package-150 sets-US-HT
• 24719874742229: CA1 Package-150 sets-US-HT
• 14719874742284: CA1 Package-25 sets-US-BR
• 14719874742253: CA0 Package-25 sets-US-BR
• 14719874742239: CA0 Package-25 sets-US-HT