Tissue-Tek®

Basic Information

• Brand Name: Tissue-Tek®
• Primary DI: 00615233013064
• Version / Model: 1550
• Catalog Number: 1550
• 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: 2020-02-23
• Public Version: 1
• Public Version Date: 2020-03-02
• Public Version Status: New
• Public Device Record Key: 750d40b5-f6d7-4a5f-92e8-6c2969bae75f

Device Description

Scraper, Large

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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IEO	PROCESSOR, TISSUE, AUTOMATED	Pathology	864.3875	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35330	Cytology scraper, reusable	A metal instrument used to collect a scraping of cells from tissue for the purposes of a diagnostic examination. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00615233013064	GS1

Customer Contacts

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