SurgiLight Disposable Handle Assembly

Basic Information

• Brand Name: SurgiLight Disposable Handle Assembly
• Primary DI: 10865082000174
• Version / Model: 2816-01-0002
• Company Name: BihlerMed, L.L.C.
• Labeler DUNS: 828549936
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-08-09
• Public Version: 3
• Public Version Date: 2023-11-06
• Public Version Status: Update
• Public Device Record Key: 5b33c8cc-a56c-42ab-a512-b14eab8c4b6b

Device Description

The Disposable Handle Assembly is a sub-assembly of the View Medical SurgiLight. The Disposable Handle Assembly attaches to the SurgiLight and is essential to the overall functionality of the surgical light. The dual purpose handle gives the user the ability to focus the light by rotating the handle and serves as a layer of protection for the light-emitting diode (LED) housing. The medical cover sleeve is extended over the SurgiLight to provide a sterile barrier to the flexible shaft.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• 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: 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	20865082000171	GS1	Box	6	In Commercial Distribution
Primary	10865082000174	GS1

Customer Contacts

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