LensHooke Sperm Separation Device

Basic Information

• Brand Name: LensHooke Sperm Separation Device
• Primary DI: 24719874742229
• Version / Model: CA1 Package-150 sets-US-HT
• Catalog Number: CA1
• Company Name: BONRAYBIO CO., LTD.
• Labeler DUNS: 658872369
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-02-16
• Public Version: 1
• Public Version Date: 2025-02-24
• Public Version Status: New
• Public Device Record Key: 5591fd3b-0b95-4d0b-9d0b-768522cb69dd

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MQK	Labware, Assisted Reproduction	Obstetrics/Gynecology	884.6160	2

GMDN Terms

Code	Name	Definition	Implantable	Status
17987	Sperm filtration system	An assembly of devices incorporating filters that separate motile sperm from nonmotile sperm and seminal fluid/plasma for use in intrauterine insemination and other forms of assisted reproduction techniques. In some systems, the semen is filtered through a mechanical matrix filter. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	24719874742229	GS1

Premarket Submissions

Submission Number	Supplement Number
K221810	000