Trak

GUDID 00860001286502

Trak 2-Test Kit, Male Fertility Testing System

SANDSTONE DIAGNOSTICS, INC.

Sperm concentration indicator IVD, kit, colorimetric dipstick, self-testing

• Primary Device ID: 00860001286502
• NIH Device Record Key: 7d00d312-0115-4642-bdb1-a9183b13d41c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Trak
• Version Model Number: TTK-0-3
• Company DUNS: 078507523
• Company Name: SANDSTONE DIAGNOSTICS, INC.
• 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: true
• Device Combination Product: false
• Single Use: true
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860001286502 [Primary]

FDA Product Code

• POV: Semen Analysis Device

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: 2021-07-01
• Device Publish Date: 2021-06-23

On-Brand Devices [Trak]

• 00860001286526: Trak Refill Kit, Male Fertility Testing System
• 00860001286519: Trak 4-Test Kit, Male Fertility Testing System
• 00860001286502: Trak 2-Test Kit, Male Fertility Testing System