Cryomold®

Basic Information

• Brand Name: Cryomold®
• Primary DI: 10615233078770
• Version / Model: 4728
• Catalog Number: 4728
• Company Name: SAKURA FINETEK U.S.A., INC.
• Labeler DUNS: 179135769
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 12
• Record Status: Published
• Publish Date: 2020-03-17
• Public Version: 2
• Public Version Date: 2023-10-03
• Public Version Status: Update
• Public Device Record Key: 45b18c06-36b3-4c27-9ad0-d4b90416a044

Device Description

Standard

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: 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
KER	Container, Embedding	Pathology	864.3010	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63791	Tissue embedding mould IVD, single-use	A plastic container of square or rectangular shape intended to be used to embed tissue specimens into an embedding medium (e.g., paraffin wax) to form a solid block, which is subsequently cut into thin sections for processing and analysis of the tissue specimen. It is typically made of synthetic polymer materials (e.g., plastic) This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10615233078770	GS1
Unit of Use	00615233078773	GS1

Customer Contacts

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