FDA.reportPublic FDA data

OPELAIII Hard Case

Primary DI
14589864500237
Brand
OPELAIII Hard Case
Company
TAIYO CORPORATION
Model
-H
Device description
Wearable Surgical Lighting System
Published
2021-04-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FQPLamp, Operating-Room
FSQLight, Surgical, Instrument
HPPHeadlamp, Operating, Battery-Operated

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FQPLamp, Operating-RoomGeneral, Plastic Surgery2
FSQLight, Surgical, InstrumentGeneral, Plastic Surgery2
HPPHeadlamp, Operating, Battery-OperatedOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14589864500237PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1458986450023714589864500237

GMDN Terms#

Term, Definition table
TermDefinition
Head-worn lampAn 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+81354406273info@opela3.com

Regulatory Flags#

DUNS number
696055151
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
14589864500282OPELAIII Protected Special Package-H2022-07-07
14589864500336OPELAIII COOLMAX® Comfort Inner Pads-H2022-07-07
14589864500350OPELAIII Attached Belt (3L)-H2022-07-07
14589864500176OPELAIII Antibacterial Urethane Pad-H2020-12-08
14589864500275OPELAIII Protected Special Package-H2021-04-07
14589864500312OPELAIII calibration kit-H2021-04-07
14589864500138OPELAIII Dedicated AC Adapter-H2020-12-08
14589864500145OPELAIII Attached Belt (M-L)-H2020-12-08
14589864500152OPELAIII Attached Belt (LL)-H2020-12-08
14589864500169OPELAIII Storage Bag (with calibration kit)-H2020-12-08
14589864500206OPELAIII Cord Clip (Small)-H2020-12-08
14589864500213OPELAIII Cord Clip (Large)-H2020-12-08
14589864500107OPELAIII Standard Package-H2020-12-07
14589864500114OPELAIII Main Unit-H2020-12-07
14589864500121OPELAIII Battery Unit-H2020-12-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810186670238Enova IlluminationEnova Illumination, Inc.HPP2026-04-08
00810186670245Enova IlluminationEnova Illumination, Inc.HPP2026-04-08
00810186670252Enova IlluminationEnova Illumination, Inc.HPP2026-04-08
00810186670269Enova IlluminationEnova Illumination, Inc.HPP2026-04-08
00810186670276Enova IlluminationEnova Illumination, Inc.HPP2026-04-08
00810186670283Enova IlluminationEnova Illumination, Inc.HPP2026-04-08
00810186670290Enova IlluminationEnova Illumination, Inc.HPP2026-04-08
00810186670306Enova IlluminationEnova Illumination, Inc.HPP2026-04-08
00810186670313Enova IlluminationEnova Illumination, Inc.HPP2026-04-08
00810186670320Enova IlluminationEnova Illumination, Inc.HPP2026-04-08
00810186670337Enova IlluminationEnova Illumination, Inc.HPP2026-04-08
00810186670344Enova IlluminationEnova Illumination, Inc.HPP2026-04-08
00810186670351Enova IlluminationEnova Illumination, Inc.HPP2026-04-08
00810186670368Enova IlluminationEnova Illumination, Inc.HPP2026-04-08
00810186670375Enova IlluminationEnova Illumination, Inc.HPP2026-04-08
00810186670382Enova IlluminationEnova Illumination, Inc.HPP2026-04-08
00810186670399Enova IlluminationEnova Illumination, Inc.HPP2026-04-08
00810186670221Enova IlluminationEnova Illumination, Inc.HPP2026-03-31
08057147028963LYNXUNIVET LOUPES SPAHPP2026-03-02
08057147028970LYNX PROUNIVET LOUPES SPAHPP2026-03-02
00810186670214Enova IlluminationEnova Illumination, Inc.HPP2026-02-27
00860015454782RocotoRocoto Inc.HPP2026-02-26
00810186670146Enova IlluminationEnova Illumination, Inc.HPP2025-12-10
00810186670153Enova IlluminationEnova Illumination, Inc.HPP2025-12-10
00810186670160Enova IlluminationEnova Illumination, Inc.HPP2025-12-10
00810186670177Enova IlluminationEnova Illumination, Inc.HPP2025-12-10
00810186670184Enova IlluminationEnova Illumination, Inc.HPP2025-12-10
00810186670191Enova IlluminationEnova Illumination, Inc.HPP2025-12-10
00810186670207Enova IlluminationEnova Illumination, Inc.HPP2025-12-10
00840277411082MedLED SpectraRIVERPOINT MEDICAL, LLCHPP2025-10-28