GLOBAL SURGICAL CORPORATION

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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

Microscope, Surgical (EPT) (10)

Premarket Exempt

Yes

Clear

400MM OBJECTIVE LENS, 20MM FINE FOCUS ADJUSTMENT, A-SERIES - 00810040250408 Catalog Number :

Device Class : 1

Duns Number: 824793335

Premarket Exempt : Yes

Product Code : EPT

Prescription Use : Yes

Device Count : 1

LASER FILTER MODULE, A-SERIES - 00810040250415 Catalog Number :

Device Class : 1

Duns Number: 824793335

Premarket Exempt : Yes

Product Code : EPT

Prescription Use : Yes

Device Count : 1

DUAL PORT BEAMSPLITTER, 50/50 AND 50/50 PORTS, A-SERIES - 00810040250422 Catalog Number :

Device Class : 1

Duns Number: 824793335

Premarket Exempt : Yes

Product Code : EPT

Prescription Use : Yes

Device Count : 1

SINGLE PORT BEAMSPLITTER, 95/5 (VIRTUAL) PORT, A-SERIES - 00810040250439 Catalog Number :

Device Class : 1

Duns Number: 824793335

Premarket Exempt : Yes

Product Code : EPT

Prescription Use : Yes

Device Count : 1

DUAL IRIS DIAPHRAGM, A-SERIES - 00810040250446 Catalog Number :

Device Class : 1

Duns Number: 824793335

Premarket Exempt : Yes

Product Code : EPT

Prescription Use : Yes

Device Count : 1

RING FLASH ADAPTER FOR M A1028-XXX A-SERIES OBJECTIVES, WITH M 62 X 0.75 FEMALE - 00810040250453 Catalog Number :

Device Class : 1

Duns Number: 824793335

Premarket Exempt : Yes

Product Code : EPT

Prescription Use : Yes

Device Count : 1

STRAIGHT CAMERA ADAPTER, C-MOUNT, HD VIDEO, A-SERIES - 00810040250460 Catalog Number :

Device Class : 1

Duns Number: 824793335

Premarket Exempt : Yes

Product Code : EPT

Prescription Use : Yes

Device Count : 1

LED LIGHT SOURCE, GREEN AND AMBER (UV) FILTER, A SERIES - 00810040250477 Catalog Number :

Device Class : 1

Duns Number: 824793335

Premarket Exempt : Yes

Product Code : EPT

Prescription Use : Yes

Device Count : 1

POWERCORD HOSPITAL GRADE TO LOCKING IEC, 10' LONG, A SERIES - 00810040250484 Catalog Number :

Device Class : 1

Duns Number: 824793335

Premarket Exempt : Yes

Product Code : EPT

Prescription Use : Yes

Device Count : 1

POWERCORD IEC MALE TO FEMALE, 6' LONG, A SERIES - 00810040250491 Catalog Number :

Device Class : 1

Duns Number: 824793335

Premarket Exempt : Yes

Product Code : EPT

Prescription Use : Yes

Device Count : 1

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