NA

Basic Information

• Brand Name: NA
• Primary DI: 20724995154213
• Version / Model: Lighthandle Cover
• Catalog Number: LB50
• Company Name: STERIS CORPORATION
• Labeler DUNS: 036985604
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 500
• Record Status: Published
• Publish Date: 2021-04-02
• Public Version: 1
• Public Version Date: 2021-04-12
• Public Version Status: New
• Public Device Record Key: c5a62562-b853-4de3-a31d-18c8bbdc10be

Device Description

The STERIS Harmony Surgical Lighting Visulization System cover and tray are a sterilizable consumable (disposable, single use) used to drape the light handle, camera housing, and flat screen monitor handles for the purpose of maintaining a sterile surgical environment.

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: Yes
• 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LRP	TRAY, SURGICAL	General, Plastic Surgery	878.4800	1
MDM	INSTRUMENT, MANUAL, SURGICAL, GENERAL USE	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
12535	Medical equipment drape, single-use	A flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or equipment components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the contents from soiling and contamination when used in the vicinity of, or entered into, a hygienic area. It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50724995154214	GS1	Case	2	In Commercial Distribution
Primary	20724995154213	GS1
Unit of Use	00724995154219	GS1

Customer Contacts

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