LensHooke Semen Quality Analyzer

GUDID 04719874740702

BONRAYBIO CO., LTD.

Spermatozoa/semen analyser IVD

• Primary Device ID: 04719874740702
• NIH Device Record Key: fa156d30-5076-4f58-8708-60bf1990f1df
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LensHooke Semen Quality Analyzer
• Version Model Number: X1 PRO
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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	04719874740702 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180343

FDA Product Code

• POV: Semen Analysis Device

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2022-09-16
• Device Publish Date: 2019-10-07

On-Brand Devices [LensHooke Semen Quality Analyzer]

• 04719874741570: X1 PRO SE
• 04719874740702: X1 PRO