ThermoBrite

Basic Information

• Brand Name: ThermoBrite
• Primary DI: 00849832002086
• Version / Model: 3800-004852-002
• Company Name: Leica Biosystems Richmond, Inc.
• Labeler DUNS: 082930884
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-09-19
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: eae11b38-de41-4b1d-b3ac-46cf1585e73f

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JRG	BLOCK, HEATING	Clinical Chemistry	862.2050	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62262	Microscope slide hybridization/denaturation incubator IVD	A mains electricity (AC-powered) laboratory instrument intended to be used for the incubation of microscope slides for the denaturation and/or hybridization of a clinical specimen as part of an in situ hybridization (ISH) and/or fluorescence in situ hybridisation (FISH) protocol. It is typically a bench-top unit with the capacity to hold multiple previously-prepared slides (i.e., fixed slides with/without added reagents) and is programmable to provide an optimum environment for ISH/FISH procedures (e.g., by controlling temperature, humidity and incubation time).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00849832002086	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify

Storage Conditions

• Type: Special Storage Condition, Specify