NA

Basic Information

• Brand Name: NA
• Primary DI: 04055207012727
• Version / Model: 4608009
• Catalog Number: 4608009
• Company Name: Richard Wolf GmbH
• Labeler DUNS: 315304071
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-03-15
• Public Version: 2
• Public Version Date: 2023-05-25
• Public Version Status: Update
• Public Device Record Key: fa602c47-f151-4cc1-8a98-a3942a805b92
• Distribution End Date: 2023-05-24

Device Description

LED HEAD SIGHT DOWN

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: 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
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	04055207012727	GS1

Customer Contacts

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