Tissue-Tek®

Basic Information

• Brand Name: Tissue-Tek®
• Primary DI: 10615233078657
• Version / Model: 4583
• Catalog Number: 4583
• Company Name: SAKURA FINETEK U.S.A., INC.
• Labeler DUNS: 179135769
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 12
• Record Status: Published
• Publish Date: 2019-12-15
• Public Version: 1
• Public Version Date: 2019-12-23
• Public Version Status: New
• Public Device Record Key: adc34b55-a240-4463-bb64-e113e8dbacde

Device Description

O.C.T. Compound

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
KEQ	MEDIA, MOUNTING, WATER SOLUBLE	Pathology	864.4010	1

GMDN Terms

Code	Name	Definition	Implantable	Status
57739	Tissue freezing/embedding medium IVD	A tissue freezing and embedding material intended to be used as an embedding matrix for the preparation and processing of frozen sections from biological tissues or clinical specimens.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10615233078657	GS1
Unit of Use	00615233078650	GS1

Customer Contacts

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