Tissue-Tek® Uni-Cassette®

Basic Information

• Brand Name: Tissue-Tek® Uni-Cassette®
• Primary DI: 00615233078186
• Version / Model: 4171-02
• Catalog Number: 4171-02
• Company Name: SAKURA FINETEK U.S.A., INC.
• Labeler DUNS: 179135769
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-01-22
• Public Version: 5
• Public Version Date: 2023-11-03
• Public Version Status: Update
• Public Device Record Key: e693bf1b-c6d3-4e46-8b7f-e2571dee1062

Device Description

White, LWS, with one storage cabinet

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• 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
KDT	CONTAINER, SPECIMEN MAILER AND STORAGE, STERILE	Pathology	864.3250	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35976	Microscope slide cabinet	A furniture-like device designed for the secure storage of many prepared laboratory specimen slides, e.g., histology microscope slides. The slides will typically be placed in dedicated trays. This device may be used, e.g., in the laboratory or a physician's office and can be locked to prevent access by an unauthorized person.	No	Active
62970	Histology tissue cassette IVD, laboratory processing, single-use	A small device intended to be used in the laboratory to support/contain clinical tissue specimens (e.g., biopsy samples) to facilitate specimen processing [e.g., fixation (encapsulation in paraffin wax), dehydration, infiltration] in preparation for subsequent cytological or histological examination, and storage. It is in the form of a plastic container, with or without a lid, with drainage holes to maximize fluid exposure during tissue submersion in a parent device into which the container is loaded. It may, in addition, include a fenestrated insert to hold and prevent the loss of a smaller specimens. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00615233078186	GS1

Customer Contacts

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