FUJIFILM NEW DEVELOPMENT U.S.A., INC.

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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

Laparoscope, General & Plastic Surgery (GCJ) (5)

Premarket Exempt

Clear

InterLock Trocar - 00856853006009 Catalog Number : 1001

Device Class : 2

Duns Number: 005065629

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

Fujifilm Surgical System - 00856853006016 Catalog Number :

Device Class : 2

Duns Number: 005065629

Premarket Exempt : No

Product Code : GCJ

Prescription Use : No

Device Count : 1

Fujifilm Surgical System - 00856853006023 Catalog Number :

Device Description : Video Processor

Device Class : 2

Duns Number: 005065629

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

Fujifilm Surgical System - 00856853006030 Catalog Number :

Device Description : Light Source

Device Class : 2

Duns Number: 005065629

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

Fujifilm Surgical System - 00856853006047 Catalog Number :

Device Class : 2

Duns Number: 005065629

Premarket Exempt : No

Product Code : GCJ

Prescription Use : No

Device Count : 1

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