Tissue-Tek®

Basic Information

• Brand Name: Tissue-Tek®
• Primary DI: 00615233009029
• Version / Model: 6021
• Catalog Number: 6021
• 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: 2020-09-05
• Public Version: 1
• Public Version Date: 2020-09-14
• Public Version Status: New
• Public Device Record Key: c6c12877-bacf-4c15-be18-05c0a23e5577

Device Description

Reagent Alcohol 70% v/v

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
PPM	General purpose reagent	Pathology	864.4010	1

GMDN Terms

Code	Name	Definition	Implantable	Status
57724	Reagent grade alcohol solution IVD	A reagent grade alcohol solution (e.g., methanol, ethanol, isopropanol) intended to be used as a dehydrant in the processing of biological tissues or clinical specimens.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00615233009012	GS1
Primary	00615233009029	GS1

Customer Contacts

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