View Medical SurgiLight

Basic Information

• Brand Name: View Medical SurgiLight
• Primary DI: 10865082000181
• Version / Model: 2816-01-0001
• Company Name: BihlerMed, L.L.C.
• Labeler DUNS: 828549936
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-08-05
• Public Version: 4
• Public Version Date: 2023-11-06
• Public Version Status: Update
• Public Device Record Key: 877370e1-8b3a-4848-af50-b5ec7beee8f0

Device Description

The SurgiLight by View Medical is a surgical lighting system that aims to provide surgeons with a safe and practical illumination device to focus on specific target areas. It mounts to the handle attachment anchor point of various overhead surgical lights, and features a long, flexible shaft that will allow the user to direct the light onto the incision from any desired angle. The View Medical SurgiLight shall be used in conjunction with the sterile Disposable Handle Assembly.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: 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
FTA	Light, Surgical, Accessories	General, Plastic Surgery	878.4580	2
FTD	Lamp, Surgical	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
12282	Operating room light	A device designed to provide a specialized source of light for illumination of a site of medical intervention. It provides a high intensity, high colour rendering field of light that minimizes shadows and the emission of heat. It typically consists of an individual light head with more than one light source which may include halogen bulbs or light-emitting diodes (LEDs), reflectors, mirrors and a mechanism to adjust the focus. This device is usually mounted to the ceiling or wall of an operating room (OR) and the mount may be included. It can be part of an OR light system comprising more than one light head.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10865082000181	GS1

Customer Contacts

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