Clarapath™ SectionStar™

GUDID 00860012688944

Automated tissue sectioning and transfer system

Clarapath, Inc.

Rotary microtome IVD

• Primary Device ID: 00860012688944
• NIH Device Record Key: 7342f718-0336-4aba-9d6e-a351f7e8f2bb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Clarapath™ SectionStar™
• Version Model Number: 810-00001
• 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	00198168976302 [Previous]
GS1	00860012688944 [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: 2024-10-30
• Device Publish Date: 2024-10-22

Devices Manufactured by Clarapath, Inc.

• 00860012688944 - Clarapath™ SectionStar™: 2024-10-30Automated tissue sectioning and transfer system
• 00860012688944 - Clarapath™ SectionStar™: 2024-10-30 Automated tissue sectioning and transfer system
• 10860012688903 - ClaraTape™ Transfer Tape: 2024-09-02 Clarapath tape is intended to assist in the cutting and transfer of tissue sections in SectionStar™ auto-sectioning machine
• 00860012688913 - ClaraCut™ Blades: 2024-09-02 Microtome blade cartridge for use in SectionStar™ auto-sectioning machine for the preparation of pathology specimens. Microtom
• 00860012688920 - ClaraBond™ Slide Coater Adhesive: 2024-09-02 Clarapath adhesive is intended to assist in the tissue transfer from the tape onto an unsoiled histology slide in SectionStar™
• 00860012688937 - ClaraMount™ Coverslip mounting medium: 2024-09-02 For use as a permanent, resin based mounting medium in histological preparations on slides produced by SectionStar™
• 00198168976302 - SectionStar: 2024-08-26