OPELAIII Protected Special Package

GUDID 14589864500275

Wearable Surgical Lighting System

TAIYO CORPORATION

Head-worn lamp
Primary Device ID14589864500275
NIH Device Record Key104fc6a8-d4f9-4f9b-abb3-00bb0ff4d020
Commercial Distribution StatusIn Commercial Distribution
Brand NameOPELAIII Protected Special Package
Version Model Number-H
Company DUNS696055151
Company NameTAIYO CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
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

Device Identifiers

Device Issuing AgencyDevice ID
GS114589864500275 [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 Date2021-04-15
Device Publish Date2021-04-07

On-Brand Devices [OPELAIII Protected Special Package]

14589864500275Wearable Surgical Lighting System
14589864500282Wearable Surgical Lighting System

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