Trak

GUDID 00862105000398

Trak Male Fertility Testing System, 1-Test Kit

MEDTOX DIAGNOSTICS, INC.

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

• Primary Device ID: 00862105000398
• NIH Device Record Key: 7aad0f2d-d8aa-4a99-8ae3-52c9017a900a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Trak
• Version Model Number: TZZ-0-1C
• Company DUNS: 118569262
• Company Name: MEDTOX 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: 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00862105000398 [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: 2022-07-13
• Device Publish Date: 2022-07-05

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