OPELAIII Antibacterial Urethane Pad

Basic Information

• Brand Name: OPELAIII Antibacterial Urethane Pad
• Primary DI: 14589864500176
• Version / Model: -H
• Company Name: TAIYO CORPORATION
• Labeler DUNS: 696055151
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-12-08
• Public Version: 2
• Public Version Date: 2022-07-08
• Public Version Status: Update
• Public Device Record Key: 41ea31b5-895a-4b7d-b702-3e73f6731a5f
• Distribution End Date: 2022-07-07

Device Description

Wearable Surgical Lighting System

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: No
• Has Expiration Date: Yes
• 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
FQP	Lamp, Operating-Room	General, Plastic Surgery	878.4580	2
FSQ	Light, Surgical, Instrument	General, Plastic Surgery	878.4580	2

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	14589864500176	GS1

Customer Contacts

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