Tissue-Tek®

Basic Information

• Brand Name: Tissue-Tek®
• Primary DI: 10615233078664
• Version / Model: 4650
• Catalog Number: 4650
• Company Name: SAKURA FINETEK U.S.A., INC.
• Labeler DUNS: 179135769
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 4
• Record Status: Published
• Publish Date: 2020-02-06
• Public Version: 2
• Public Version Date: 2020-12-04
• Public Version Status: Update
• Public Device Record Key: da0e9c5f-71eb-436f-a0ba-db5d46666885

Device Description

Cold Plate

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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IDO	MICROTOME, ROTARY	Pathology	864.3010	1

GMDN Terms

Code	Name	Definition	Implantable	Status
36416	Tissue embedding unit IVD	An electrically-powered, electronic unit intended to be used in the laboratory for encapsulating (embedding) histologic tissue samples in liquid paraffin wax which when cooled and fixed to a sample holder can be further processed, e.g., placed in a microtome for cutting into samples for microscopy and/or for histological storage. This device will typically have a large storage capacity for the liquid paraffin (e.g., 4 litres) with heating facilities and heated work area, excess paraffin drainage facility, a cold plate area, and possibly a built-in forceps heater.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10615233078664	GS1
Unit of Use	00615233078667	GS1

Customer Contacts

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