ThermoBrite

GUDID 00849832002109

Leica Biosystems Richmond, Inc.

Microscope slide hybridization/denaturation incubator IVD

• Primary Device ID: 00849832002109
• NIH Device Record Key: 796c786d-ceae-4bb3-b1c1-2d66c0355aed
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ThermoBrite
• Version Model Number: 3800-004852-004
• Company DUNS: 082930884
• Company Name: Leica Biosystems Richmond, 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

Customer Support Contacts

• Phone: +1(844)5342262
• Email: tech.support@Leicabiosystems.com

Device Dimensions

• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *

Device Identifiers

Device Issuing Agency	Device ID
GS1	00849832002109 [Primary]

FDA Product Code

• JRG: BLOCK, HEATING

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-09-19