ClaraMount™ Coverslip mounting medium

GUDID 00860012688937

For use as a permanent, resin based mounting medium in histological preparations on slides produced by SectionStar™

Clarapath, Inc.

Microscopy mounting medium IVD

• Primary Device ID: 00860012688937
• NIH Device Record Key: 19995e56-c2b1-4755-84e6-43f0986e7ca4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ClaraMount™ Coverslip mounting medium
• Version Model Number: 900-00023
• 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: 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860012688937 [Primary]
GS1	10860012688934 [Package]; Package: [4 Units]; In Commercial Distribution

FDA Product Code

• LEB: Mounting Media

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: 2024-09-02
• Device Publish Date: 2024-08-23

Devices Manufactured by Clarapath, Inc.

• 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: 2024-09-02For use as a permanent, resin based mounting medium in histological preparations on slides produced by 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