LensHooke X QC Video (For Semen) X QC Video

GUDID 04719874741099

BONRAYBIO CO., LTD.

Sperm concentration indicator IVD, control

• Primary Device ID: 04719874741099
• NIH Device Record Key: 4753ad17-6c43-42b6-ab59-f102601b06a8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LensHooke X QC Video (For Semen)
• Version Model Number: QXB set package-US HT
• Catalog Number: X QC Video
• 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: true
• Expiration Date: false
• 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	04719874741099 [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: 2021-01-01
• Device Publish Date: 2020-12-24

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

• 04719874741099: QXB set package-US HT
• 04719874741082: QXB set package-US BR
• 04719874741051: QXB V2 package
• 04719874741044: QXB V1 package
• 04719874741037: QXB V0 package