Tissue-Tek® Glas™ g2

Basic Information

• Brand Name: Tissue-Tek® Glas™ g2
• Primary DI: 00615233080646
• Version / Model: 6417
• Catalog Number: 6417
• Company Name: SAKURA FINETEK U.S.A., INC.
• Labeler DUNS: 179135769
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-02-06
• Public Version: 2
• Public Version Date: 2020-08-20
• Public Version Status: Update
• Public Device Record Key: 699ecafd-2670-4167-8601-827bf9dcafe0

Device Description

Coverslips 24 x 60 mm; 200 coverslips; 5 holders/case

Device Characteristics

• Single Use: Yes
• 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: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KES	COVERSLIPS, MICROSCOPE SLIDE	Pathology	864.3010	1

GMDN Terms

Code	Name	Definition	Implantable	Status
42833	Microscope slide holder, preparation/staining	A holder used in the laboratory to hold microscope slides in an upright position during the preparation or staining procedures. It is typically made of plastic materials, will sit sturdily upon a flat surface (e.g., a laboratory bench top or on a shelf) and has a series of spaced slots into which the slides are placed. This is a reusable device.	No	Active
15687	Microscope slide coverslip IVD	A thin piece of glass or a plastic sheath placed over a specimen on a microscope slide, to serve as a physical barrier to protect the specimen from mechanical forces and environmental exposure. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00615233080646	GS1

Customer Contacts

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