NA

Basic Information

• Brand Name: NA
• Primary DI: 04055207008751
• Version / Model: 452600
• Catalog Number: 4526.00
• Company Name: Richard Wolf GmbH
• Labeler DUNS: 315304071
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-10-17
• Public Version: 4
• Public Version Date: 2023-05-17
• Public Version Status: Update
• Public Device Record Key: cd61a53b-eff0-43c2-8bb5-dbd867126eb8
• Distribution End Date: 2021-05-25

Device Description

HEADLAMP reusable

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: 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
FCT	Headlight, fiberoptic focusing	Ophthalmic	886.4335	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46808	Head-worn fibreoptic light	A fibreoptic device mounted on a headband or helmet frame to convey cold light from a connected light source (not included) directly onto the field of vision during a medical or surgical procedure. It typically consists of a magnifying lens, a reflector, and a fibreoptic cable.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04055207008751	GS1

Customer Contacts

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