Histo-Tek®

Basic Information

• Brand Name: Histo-Tek®
• Primary DI: 00615233007940
• Version / Model: 4221
• Catalog Number: 4221
• 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: 2020-03-31
• Public Version: 2
• Public Version Date: 2021-11-23
• Public Version Status: Update
• Public Device Record Key: b9af10eb-ab04-4898-af9d-6cb4260c3787

Device Description

Biopsy Bags, Medium (4.5 x 6.5 cm); 500/box

Device Characteristics

• Single Use: Yes
• 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: No
• Has Manufacturing Date: No
• 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
NNK	CONTAINER, SPECIMEN MAILER AND STORAGE, NON-STERILE	Pathology	864.3250	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63784	Histological tissue cassette biopsy insert IVD	A flexible and porous material designed to securely hold a biopsy specimen within a tissue cassette, to prevent loss of the specimen during laboratory specimen processing (e.g., fixation, dehydration, infiltration) in preparation for subsequent cytological or histological examination. The flexible and porous material (e.g., paper, synthetic polymer) is intended to allow infiltration of reagents and maximize fluid-exchange during tissue processing. It is available in various forms (e.g., sheet, bag, foam pad) and is placed in a tissue processing cassette, with the biopsy specimen wrapped or contained inside it. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00615233007940	GS1

Customer Contacts

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