ION MEDICAL, INC.

Address:5329 Fairmont St,Jacksonville,FL,32207,US

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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

Electrosurgical, Cutting & Coagulation & Accessories (GEI) (8)

Premarket Exempt

Clear

Ion Coagulation Pen - B9122018502 Catalog Number :

Device Description : 18 Gauge Bipolar Coagulation Pen

Device Class :

Duns Number: 020795679

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 10

Ion Coagulation Pen - B9122018602 Catalog Number :

Device Description : 18 Gauge Curved Bipolar Coagulation Pen

Device Class : 2

Duns Number: 020795679

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 10

Ion Coagulation Pen - B9122020102 Catalog Number :

Device Description : 20 Gauge Bipolar Coagulation Pen

Device Class : 2

Duns Number: 020795679

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 10

Ion Coagulation Pen - B9122023102 Catalog Number :

Device Description : 23 Gauge Fine Point Bipolar Coagulation Pen

Device Class : 2

Duns Number: 020795679

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 5

Ion Coagulation Pen - B9122023152 Catalog Number :

Device Description : 20-23 Gauge Fine Point Bipolar Coagulation Pen

Device Class : 2

Duns Number: 020795679

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 5

Ion Coagulation Pen - B9122023162 Catalog Number :

Device Description : 20-23 Gauge Blunt Point Bipolar Coagulation Pen

Device Class : 2

Duns Number: 020795679

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 5

Ion Coagulation Pen - B9122025302 Catalog Number :

Device Description : 25 Gauge Fine Point Bipolar Coagulation Pen

Device Class : 2

Duns Number: 020795679

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 5

Ion Coagulation Pen - B9122027302 Catalog Number :

Device Description : 27 Gauge Fine Point Bipolar Coagulation Pen

Device Class : 2

Duns Number: 020795679

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 5

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