Tissue-Tek®

Basic Information

• Brand Name: Tissue-Tek®
• Primary DI: 00615233013897
• Version / Model: 4151
• Catalog Number: 4151
• 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: 1
• Public Version Date: 2020-01-30
• Public Version Status: New
• Public Device Record Key: 9dee2277-1ce6-4d4c-aaba-d9dfee3b5d06

Device Description

Embedding Ring, White

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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KER	CONTAINER, EMBEDDING	Pathology	864.3010	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63813	Tissue embedding mould holder IVD	A preformed plastic device intended to contain and hold a tissue embedding mould during an embedding procedure (e.g., in paraffin wax) to form a tissue solid block, which is subsequently cut into thin sections for processing and analysis of the tissue specimen. It may also be referred to as an embedding ring and typically has a writing surface to facilitate specimen identification. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00615233013897	GS1

Customer Contacts

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