Clarapath™ SectionStar™

GUDID 00860012688968

Automated tissue sectioning and transfer system, V2

Clarapath, Inc.

Rotary microtome IVD

• Primary Device ID: 00860012688968
• NIH Device Record Key: efc7043d-afbe-4cff-97ab-d82da581d870
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Clarapath™ SectionStar™
• Version Model Number: 810-00002
• Company DUNS: 079469240
• Company Name: Clarapath, 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: false
• Serial Number: true
• 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	00860012688968 [Primary]

FDA Product Code

• IDO: Microtome, Rotary

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: 2025-02-12
• Device Publish Date: 2025-02-04

On-Brand Devices [Clarapath™ SectionStar™]

• 00860012688944: Automated tissue sectioning and transfer system
• 00860012688968: Automated tissue sectioning and transfer system, V2