Rechargeable Light Source

Basic Information

• Brand Name: Rechargeable Light Source
• Primary DI: 00714646001375
• Version / Model: 3600
• Catalog Number: 3600
• Company Name: Bionix, LLC
• Labeler DUNS: 117844489
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2025-02-25
• Public Version: 2
• Public Version Date: 2025-03-14
• Public Version Status: Update
• Public Device Record Key: 48458b23-6ee7-47f7-953e-ee1288b8205f

Device Description

Rechargeable Light Source with Magnification Lens

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: Yes
• 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
KYT	LIGHT, EXAMINATION, MEDICAL, BATTERY POWERED	General Hospital	880.6350	1

GMDN Terms

Code	Name	Definition	Implantable	Status
65447	ENT instrument light source	An electrically-powered, noninvasive device intended to be attached to the proximal end of an appropriate ear/nose/throat (ENT) instrument (e.g., curette or forceps) [not included] to produce light and facilitate visualization. It is designed for use with an instrument with light transmitting features; it is not intended for endoscopic use. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	10714646001372	GS1
Primary	00714646001375	GS1

Customer Contacts

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