Tissue-Tek Xpress®

Basic Information

• Brand Name: Tissue-Tek Xpress®
• Primary DI: 10615233081497
• Version / Model: 7115
• Catalog Number: 7115
• 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: 2019-12-15
• Public Version: 1
• Public Version Date: 2019-12-23
• Public Version Status: New
• Public Device Record Key: 83b6c072-93f3-4e41-b40f-288bcbf1778e

Device Description

Pre-Processing Solution

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
LDZ	FIXATIVE, ALCOHOL CONTAINING	Pathology	864.4010	1
PPM	General purpose reagent	Pathology	864.4010	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63938	Histology tissue processing reagent kit IVD	A collection of reagents intended to be used for tissue processing in a histology laboratory to prepare biological tissues or clinical tissue specimens for embedding, or related procedures, by successively removing water and alcohol. It may consist of a fixative (e.g., formalin), a dehydrating agent (e.g., alcohol) and a clearing reagent (e.g., xylene).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10615233081497	GS1
Unit of Use	00615233081490	GS1

Customer Contacts

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