Tissue-Tek® Paraform®

Basic Information

• Brand Name: Tissue-Tek® Paraform®
• Primary DI: 00615233010568
• Version / Model: 7188
• Catalog Number: 7188
• 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: 2022-11-08
• Public Version: 1
• Public Version Date: 2022-11-16
• Public Version Status: New
• Public Device Record Key: 2a5a2129-1746-4c48-ae0e-49a9636b66c1

Device Description

PM Printer Adapter

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
IDZ	Cassettes, Tissue	Pathology	864.3010	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63186	Immunoassay reagent vehicle tray IVD, reusable	A removable tray designed to be loaded with an immunoassay reagent vehicle (e.g., test strip, cassette, card), after vehicle exposure to an in vitro diagnostic clinical specimen, and inserted into an immunoassay analyser. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00615233010568	GS1

Customer Contacts

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