OPELAIII Main Unit

GUDID 14589864500114

Wearable Surgical Lighting System

TAIYO CORPORATION

Head-worn lamp Head-worn lamp Head-worn lamp Head-worn lamp Head-worn lamp Head-worn lamp Head-worn lamp Head-worn lamp Head-worn lamp Head-worn lamp Head-worn lamp Head-worn lamp Head-worn lamp Head-worn lamp Head-worn lamp

• Primary Device ID: 14589864500114
• NIH Device Record Key: 2fc2632f-c588-4e11-bc19-acd34bef0fb9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OPELAIII Main Unit
• Version Model Number: -H
• Company DUNS: 696055151
• Company Name: TAIYO CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +81354406273
• Email: info@opela3.com
• Phone: +81354406273
• Email: info@opela3.com
• Phone: +81354406273
• Email: info@opela3.com
• Phone: +81354406273
• Email: info@opela3.com
• Phone: +81354406273
• Email: info@opela3.com
• Phone: +81354406273
• Email: info@opela3.com
• Phone: +81354406273
• Email: info@opela3.com
• Phone: +81354406273
• Email: info@opela3.com
• Phone: +81354406273
• Email: info@opela3.com
• Phone: +81354406273
• Email: info@opela3.com
• Phone: +81354406273
• Email: info@opela3.com
• Phone: +81354406273
• Email: info@opela3.com
• Phone: +81354406273
• Email: info@opela3.com
• Phone: +81354406273
• Email: info@opela3.com
• Phone: +81354406273
• Email: info@opela3.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	14589864500114 [Primary]

FDA Product Code

• HPP: Headlamp, Operating, Battery-Operated

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-12-15
• Device Publish Date: 2020-12-07

Devices Manufactured by TAIYO CORPORATION

• 14589864500282 - OPELAIII Protected Special Package: 2022-07-15 Wearable Surgical Lighting System
• 14589864500336 - OPELAIII COOLMAX® Comfort Inner Pads: 2022-07-15 Wearable Surgical Lighting System
• 14589864500350 - OPELAIII Attached Belt (3L): 2022-07-15 Wearable Surgical Lighting System
• 14589864500237 - OPELAIII Hard Case: 2021-04-15 Wearable Surgical Lighting System
• 14589864500275 - OPELAIII Protected Special Package: 2021-04-15 Wearable Surgical Lighting System
• 14589864500312 - OPELAIII calibration kit: 2021-04-15 Wearable Surgical Lighting System
• 14589864500138 - OPELAIII Dedicated AC Adapter: 2020-12-16 Wearable Surgical Lighting System
• 14589864500145 - OPELAIII Attached Belt (M-L): 2020-12-16 Wearable Surgical Lighting System