Tissue-Tek®

Basic Information

• Brand Name: Tissue-Tek®
• Primary DI: 10615233078688
• Version / Model: 4658
• Catalog Number: 4658
• Company Name: SAKURA FINETEK U.S.A., INC.
• Labeler DUNS: 179135769
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2020-02-06
• Public Version: 1
• Public Version Date: 2020-02-14
• Public Version Status: New
• Public Device Record Key: 2898d089-5bd1-4f91-9c7a-8baaaebc2ef2

Device Description

Waste Collection Bags

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
IDO	MICROTOME, ROTARY	Pathology	864.3010	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63297	Laboratory waste receptacle liner IVD	A device made of disposable materials intended to be placed inside a reusable waste receptacle for the collection and containment of waste, including biologically-contaminated waste products, resulting from in vitro diagnostic procedures. It creates a barrier to contamination, reduces cleaning requirements, and protects the waste receptacle from damage. It is typically made of synthetic polymer materials and should be discarded, with its waste content, according to the environmental legislation by which the user is bound (e.g., incineration, recycling, landfill). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10615233078688	GS1
Unit of Use	00615233078681	GS1

Customer Contacts

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