SurgiLight Adapter - Skytron

Basic Information

• Brand Name: SurgiLight Adapter - Skytron
• Primary DI: 10865082000105
• Version / Model: 2816-01-0004
• 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: 2
• Public Version Date: 2023-11-06
• Public Version Status: Update
• Public Device Record Key: 7962bcf9-5ec6-432a-a600-41006b11a420

Device Description

An adapter used specifically to secure the View Medical SurgiLight to the light handle of operating room compatible overhead Skytron® Surgical Lights.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• 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

GMDN Terms

Code	Name	Definition	Implantable	Status
64132	Medical equipment handle cover adaptor	A connecting device intended to be used to connect the handle of a piece of medical equipment (e.g., operating light) with a handle cover, when these are incompatible and are of a different manufacture/industry standard. It is made of polymer and/or metallic materials and takes a form suitable for the devices to which it connects. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10865082000105	GS1

Customer Contacts

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