NA

Basic Information

• Brand Name: NA
• Primary DI: 10724995172562
• Version / Model: LB82
• Catalog Number: LB82
• Company Name: STERIS CORPORATION
• Labeler DUNS: 036985604
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2020-05-14
• Public Version: 3
• Public Version Date: 2022-11-09
• Public Version Status: Update
• Public Device Record Key: e6e97227-98c1-44c3-be49-a2783dfe8a22

Device Description

The Universal Light Handle Cover is used with STERIS Lighting and Visualization Systems.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FTA	Light, surgical, accessories	General, Plastic Surgery	878.4580	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44977	Medical equipment handle cover, single-use	A device designed specifically to cover the handle of a piece of medical equipment (e.g., operating light) to provide a physical sterile barrier between the handle and the hand of a healthcare professional, e.g., during a surgical procedure. It is typically a polymer device designed for attachment to a handle and may in addition provide grip for improved manipulation of the handle; it is not designed to cover other equipment components. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50724995172560	GS1	Case	100	In Commercial Distribution
Primary	10724995172562	GS1
Unit of Use	00724995172565	GS1

Customer Contacts

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