LensHooke X QC Reticle (For Semen) X QC Reticle

GUDID 04719874740900

BONRAYBIO CO., LTD.

Sperm concentration indicator IVD, control

• Primary Device ID: 04719874740900
• NIH Device Record Key: 9510799e-a693-4a40-b623-322c7bec7530
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LensHooke X QC Reticle (For Semen)
• Version Model Number: X QC Reticle - L2_BR USA CORP.
• Catalog Number: X QC Reticle
• Company DUNS: 658872369
• Company Name: BONRAYBIO CO., LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: 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	04719874740900 [Primary]

FDA Product Code

• NRF: Material, Quality Control, Semen Analysis

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: 2020-03-24
• Device Publish Date: 2020-03-16

On-Brand Devices [LensHooke X QC Reticle (For Semen)]

• 04719874740900: X QC Reticle - L2_BR USA CORP.
• 04719874740894: X QC Reticle - L1_BR USA CORP.
• 04719874740887: X QC Reticle - L0_BR USA CORP.
• 04719874740870: 04719874740887 LensHooke X QC Reticle (For Semen)-L0 04719874740894 LensHooke X QC Reticle (For
• 04719874740863: X QC Reticle - L2_US
• 04719874740856: X QC Reticle - L1_US
• 04719874740849: X QC Reticle - L0_US
• 04719874740832: 04719874740849 LensHooke X QC Reticle (For Semen)- L0 04719874740856 LensHooke X QC Reticle (For