Tissue-Tek ClearFIX®

Basic Information

• Brand Name: Tissue-Tek ClearFIX®
• Primary DI: 10615233080186
• Version / Model: 5996
• Catalog Number: 5996
• 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: 00b63f55-d98e-4ee2-aef5-010a7b363b22

Device Description

Buffered Formalin Fixative

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
IFP	FORMALIN, NEUTRAL BUFFERED	Pathology	864.4010	1

GMDN Terms

Code	Name	Definition	Implantable	Status
57757	10% Neutral buffered formalin IVD	A 10% neutral buffered formalin solution intended to be used as a fixative in the processing of biological tissues or clinical specimens.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10615233080186	GS1
Unit of Use	00615233080189	GS1

Customer Contacts

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