TAIYO CORPORATION

Address:Fuji Bldg.9F., 5-30-9 Shiba,Minato-ku Tokyo,JP

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Headlamp, Operating, Battery-Operated (HPP) (10) Lamp, Operating-Room (FQP) (10) Light, Surgical, Instrument (FSQ) (10)

Premarket Exempt

Yes

Clear

OPELAIII Standard Package - 14589864500107 Catalog Number :

Device Description : Wearable Surgical Lighting System

Device Class : 1

Duns Number: 696055151

Premarket Exempt : Yes

Product Code : HPP, FQP, FSQ

Prescription Use : Yes

Device Count : 1

OPELAIII Main Unit - 14589864500114 Catalog Number :

Device Description : Wearable Surgical Lighting System

Device Class : 1

Duns Number: 696055151

Premarket Exempt : Yes

Product Code : HPP, FQP, FSQ

Prescription Use : Yes

Device Count : 1

OPELAIII Battery Unit - 14589864500121 Catalog Number :

Device Description : Wearable Surgical Lighting System

Device Class : 1

Duns Number: 696055151

Premarket Exempt : Yes

Product Code : HPP, FQP, FSQ

Prescription Use : Yes

Device Count : 1

OPELAIII Dedicated AC Adapter - 14589864500138 Catalog Number :

Device Description : Wearable Surgical Lighting System

Device Class : 1

Duns Number: 696055151

Premarket Exempt : Yes

Product Code : HPP, FQP, FSQ

Prescription Use : Yes

Device Count : 1

OPELAIII Attached Belt (M-L) - 14589864500145 Catalog Number :

Device Description : Wearable Surgical Lighting System

Device Class : 1

Duns Number: 696055151

Premarket Exempt : Yes

Product Code : HPP, FQP, FSQ

Prescription Use : Yes

Device Count : 1

OPELAIII Attached Belt (LL) - 14589864500152 Catalog Number :

Device Description : Wearable Surgical Lighting System

Device Class : 1

Duns Number: 696055151

Premarket Exempt : Yes

Product Code : HPP, FQP, FSQ

Prescription Use : Yes

Device Count : 1

OPELAIII Storage Bag (with calibration kit) - 14589864500169 Catalog Number :

Device Description : Wearable Surgical Lighting System

Device Class : 1

Duns Number: 696055151

Premarket Exempt : Yes

Product Code : HPP, FQP, FSQ

Prescription Use : Yes

Device Count : 1

OPELAIII Antibacterial Urethane Pad - 14589864500176 Catalog Number :

Device Description : Wearable Surgical Lighting System

Device Class : 1

Duns Number: 696055151

Premarket Exempt : Yes

Product Code : HPP, FQP, FSQ

Prescription Use : Yes

Device Count : 1

OPELAIII Cord Clip (Small) - 14589864500206 Catalog Number :

Device Description : Wearable Surgical Lighting System

Device Class : 1

Duns Number: 696055151

Premarket Exempt : Yes

Product Code : HPP, FQP, FSQ

Prescription Use : Yes

Device Count : 1

OPELAIII Cord Clip (Large) - 14589864500213 Catalog Number :

Device Description : Wearable Surgical Lighting System

Device Class : 1

Duns Number: 696055151

Premarket Exempt : Yes

Product Code : HPP, FQP, FSQ

Prescription Use : Yes

Device Count : 1

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