GENICON, 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) Cannula, Surgical, General & Plastic Surgery (GEA) (1) Electrosurgical, Cutting & Coagulation & Accessories (GEI) (1)

Premarket Exempt

No Yes

Clear

GeniLook - 00877972007265 Catalog Number :

Device Class : 1

Duns Number: 079805400

Premarket Exempt : No

Product Code : GEA

Prescription Use : No

Device Count : 1

2EZee Specimen Retrieval - 00877972007289 Catalog Number :

Device Class : 2

Duns Number: 079805400

Premarket Exempt : No

Product Code : GCJ

Prescription Use : No

Device Count : 1

Probe - 00877972007319 Catalog Number :

Device Class : 2

Duns Number: 079805400

Premarket Exempt : No

Product Code : GCJ

Prescription Use : No

Device Count : 1

Probe - 00877972007333 Catalog Number :

Device Class : 2

Duns Number: 079805400

Premarket Exempt : No

Product Code : GCJ

Prescription Use : No

Device Count : 1

GeniSurge - 00877972007357 Catalog Number :

Device Class : 2

Duns Number: 079805400

Premarket Exempt : No

Product Code : GEI

Prescription Use : No

Device Count : 1

Simply EZee - 00877972007371 Catalog Number :

Device Class : 2

Duns Number: 079805400

Premarket Exempt : No

Product Code : GCJ

Prescription Use : No

Device Count : 1

Simply EZee - 00877972007395 Catalog Number :

Device Class : 2

Duns Number: 079805400

Premarket Exempt : No

Product Code : GCJ

Prescription Use : No

Device Count : 1

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