Tissue-Tek Xpress®

Basic Information

• Brand Name: Tissue-Tek Xpress®
• Primary DI: 00615233081568
• Version / Model: 7150
• Catalog Number: 7150
• 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: 2019-12-15
• Public Version: 1
• Public Version Date: 2019-12-23
• Public Version Status: New
• Public Device Record Key: b91bf375-33e6-4e1b-b252-4b8084dbfbcd

Device Description

Processing Reagent Set, Formula 3

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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KEO	FORMULATIONS, PARAFFIN, ALL	Pathology	864.4010	1
LDZ	FIXATIVE, ALCOHOL CONTAINING	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	00615233081568	GS1

Customer Contacts

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