OPELAIII Antibacterial Urethane Pad

GUDID 14589864500176

Wearable Surgical Lighting System

TAIYO CORPORATION

Head-worn lamp
Primary Device ID14589864500176
NIH Device Record Key41ea31b5-895a-4b7d-b702-3e73f6731a5f
Commercial Distribution StatusIn Commercial Distribution
Brand NameOPELAIII Antibacterial Urethane Pad
Version Model Number-H
Company DUNS696055151
Company NameTAIYO CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+81354406273
Emailinfo@opela3.com
Phone+81354406273
Emailinfo@opela3.com
Phone+81354406273
Emailinfo@opela3.com
Phone+81354406273
Emailinfo@opela3.com
Phone+81354406273
Emailinfo@opela3.com
Phone+81354406273
Emailinfo@opela3.com
Phone+81354406273
Emailinfo@opela3.com
Phone+81354406273
Emailinfo@opela3.com
Phone+81354406273
Emailinfo@opela3.com
Phone+81354406273
Emailinfo@opela3.com
Phone+81354406273
Emailinfo@opela3.com
Phone+81354406273
Emailinfo@opela3.com
Phone+81354406273
Emailinfo@opela3.com
Phone+81354406273
Emailinfo@opela3.com
Phone+81354406273
Emailinfo@opela3.com
Phone+81354406273
Emailinfo@opela3.com
Phone+81354406273
Emailinfo@opela3.com
Phone+81354406273
Emailinfo@opela3.com
Phone+81354406273
Emailinfo@opela3.com
Phone+81354406273
Emailinfo@opela3.com
Phone+81354406273
Emailinfo@opela3.com
Phone+81354406273
Emailinfo@opela3.com

Device Identifiers

Device Issuing AgencyDevice ID
GS114589864500176 [Primary]

FDA Product Code

HPPHeadlamp, Operating, Battery-Operated

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-12-16
Device Publish Date2020-12-08

Devices Manufactured by TAIYO CORPORATION

14589864500282 - OPELAIII Protected Special Package2022-07-15 Wearable Surgical Lighting System
14589864500336 - OPELAIII COOLMAX® Comfort Inner Pads2022-07-15 Wearable Surgical Lighting System
14589864500350 - OPELAIII Attached Belt (3L)2022-07-15 Wearable Surgical Lighting System
14589864500237 - OPELAIII Hard Case2021-04-15 Wearable Surgical Lighting System
14589864500275 - OPELAIII Protected Special Package2021-04-15 Wearable Surgical Lighting System
14589864500312 - OPELAIII calibration kit2021-04-15 Wearable Surgical Lighting System
14589864500138 - OPELAIII Dedicated AC Adapter2020-12-16 Wearable Surgical Lighting System
14589864500145 - OPELAIII Attached Belt (M-L)2020-12-16 Wearable Surgical Lighting System

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.