Torq

GUDID 00862105000336

Torq ZDrive MR

SANDSTONE DIAGNOSTICS, INC.

General-purpose tabletop centrifuge General-purpose tabletop centrifuge General-purpose tabletop centrifuge General-purpose tabletop centrifuge General-purpose tabletop centrifuge General-purpose tabletop centrifuge General-purpose tabletop centrifuge General-purpose tabletop centrifuge General-purpose tabletop centrifuge General-purpose tabletop centrifuge General-purpose tabletop centrifuge General-purpose tabletop centrifuge General-purpose tabletop centrifuge General-purpose tabletop centrifuge General-purpose tabletop centrifuge General-purpose tabletop centrifuge General-purpose tabletop centrifuge General-purpose tabletop centrifuge General-purpose tabletop centrifuge General-purpose tabletop centrifuge General-purpose tabletop centrifuge General-purpose tabletop centrifuge General-purpose tabletop centrifuge General-purpose tabletop centrifuge General-purpose tabletop centrifuge General-purpose tabletop centrifuge General-purpose tabletop centrifuge General-purpose tabletop centrifuge General-purpose tabletop centrifuge General-purpose tabletop centrifuge General-purpose tabletop centrifuge General-purpose tabletop centrifuge General-purpose tabletop centrifuge General-purpose tabletop centrifuge General-purpose tabletop centrifuge General-purpose tabletop centrifuge General-purpose tabletop centrifuge General-purpose tabletop centrifuge General-purpose tabletop centrifuge General-purpose tabletop centrifuge General-purpose tabletop centrifuge General-purpose tabletop centrifuge General-purpose tabletop centrifuge General-purpose tabletop centrifuge General-purpose tabletop centrifuge General-purpose tabletop centrifuge General-purpose tabletop centrifuge General-purpose tabletop centrifuge General-purpose tabletop centrifuge General-purpose tabletop centrifuge General-purpose tabletop centrifuge General-purpose tabletop centrifuge General-purpose tabletop centrifuge General-purpose tabletop centrifuge General-purpose tabletop centrifuge General-purpose tabletop centrifuge General-purpose tabletop centrifuge General-purpose tabletop centrifuge General-purpose tabletop centrifuge General-purpose tabletop centrifuge General-purpose tabletop centrifuge General-purpose tabletop centrifuge General-purpose tabletop centrifuge General-purpose tabletop centrifuge General-purpose tabletop centrifuge General-purpose tabletop centrifuge General-purpose tabletop centrifuge General-purpose centrifuge IVD General-purpose centrifuge IVD General-purpose centrifuge IVD General-purpose centrifuge IVD General-purpose centrifuge IVD General-purpose centrifuge IVD General-purpose centrifuge IVD

• Primary Device ID: 00862105000336
• NIH Device Record Key: b8a009b0-48ba-435a-8a94-49ed15a2233a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Torq
• Version Model Number: ZEA-MR-1
• Company DUNS: 078507523
• Company Name: SANDSTONE DIAGNOSTICS, INC.
• 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: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00862105000336 [Primary]

FDA Product Code

• JQC: Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use

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: 2021-01-13
• Device Publish Date: 2021-01-05

Devices Manufactured by SANDSTONE DIAGNOSTICS, INC.

• 00860001286502 - Trak: 2021-07-01 Trak 2-Test Kit, Male Fertility Testing System
• 00860001286519 - Trak: 2021-07-01 Trak 4-Test Kit, Male Fertility Testing System
• 00860001286526 - Trak: 2021-07-01 Trak Refill Kit, Male Fertility Testing System
• 00862105000336 - Torq: 2021-01-13Torq ZDrive MR
• 00862105000336 - Torq: 2021-01-13 Torq ZDrive MR