ELMED INCORPORATED

Basic Information

• Brand Name: ELMED INCORPORATED
• Primary DI: 00198506073489
• Version / Model: 9802-02
• Catalog Number: 9802-02
• Company Name: ELMED INCORPORATED
• Labeler DUNS: 049290364
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-11-19
• Public Version: 1
• Public Version Date: 2024-11-27
• Public Version Status: New
• Public Device Record Key: 93b7c33c-9fe1-4d64-924e-1b8d4ffa43ab

Device Description

ELMED HANDY III PORTABLE LED LIGHT-SOURCE WITH RECHARGEABLE BATTERY AND BATTERY CHARGER

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: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HPP	Headlamp, Operating, Battery-Operated	Ophthalmic	886.4335	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46807	Head-worn lamp	An electrically-powered lamp mounted on a headband, helmet frame, or spectacles and intended to provide light directly onto the field of vision during a dental or surgical procedure. The light typically consists of a magnifying lens, a reflector, a light bulb, and a connection to its integral batteries or battery pack; it is not a fibreoptic light.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00198506073489	GS1

Customer Contacts

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