Tissue-Tek® Lab Aid® Ultra™ II

Basic Information

• Brand Name: Tissue-Tek® Lab Aid® Ultra™ II
• Primary DI: 08720177655569
• Version / Model: 3980
• Catalog Number: 3980
• 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: 1
• Public Version Date: 2020-06-29
• Public Version Status: New
• Public Device Record Key: 3bc96e8e-3795-4d85-abac-2ced196f1dff

Device Description

Trolley

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: 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
47081	Endoscope transport trolley tray	A support platform designed as a flat, shallow vessel with a raised rim, that functions as a component of an endoscope transport trolley [i.e., it inserts into the trolley (cart)]. It provides a protective space for the transport and short-term storage of a sterile or contaminated endoscope, endoscope accessories, or other sensitive equipment. It is typically made from plastic materials, is available in a variety of sizes, and may be fitted with a cover lid. This is a reusable device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08720177655569	GS1

Customer Contacts

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