Tissue-Tek® Cryo3®

Basic Information

• Brand Name: Tissue-Tek® Cryo3®
• Primary DI: 00615233009227
• Version / Model: 6201
• Catalog Number: 6201
• 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: 2020-06-20
• Public Version: 2
• Public Version Date: 2020-12-21
• Public Version Status: Update
• Public Device Record Key: 9e2d3e64-31e0-420a-b440-8e6c06acdbcb

Device Description

Flex Cryostat, D

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: Yes
• Has Lot/Batch Number: No
• 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
IDP	MICROTOME, CRYOSTAT	Pathology	864.3010	1

GMDN Terms

Code	Name	Definition	Implantable	Status
15157	Cryostat microtome IVD	A precision cutting instrument contained within a temperature-controlled cabinet (i.e., a cryostat) intended to be used for the sectioning of rapidly-frozen tissue specimens without prior fixation to expedite subsequent in vitro diagnostic analysis of the tissue specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00615233009227	GS1

Customer Contacts

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