Tissue-Tek®

Basic Information

• Brand Name: Tissue-Tek®
• Primary DI: 14560133242171
• Version / Model: 4770
• Catalog Number: 4770
• Company Name: SAKURA FINETEK U.S.A., INC.
• Labeler DUNS: 179135769
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2019-12-15
• Public Version: 2
• Public Version Date: 2020-08-20
• Public Version Status: Update
• Public Device Record Key: b9598953-a645-4791-8151-031f99b6f34b

Device Description

Coverslipping Film

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: 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
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	14560133242171	GS1
Unit of Use	04560133242174	GS1

Customer Contacts

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