DOMAIN SURGICAL, 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

Electrosurgical, Cutting & Coagulation & Accessories (GEI) (7)

Premarket Exempt

Clear

FMwand - 00859729006110 Catalog Number : FM2102S

Device Description : FMwand Handpiece with Integrated Smoke Evacuation - 100 mm Length with 5 mm Resecting Loop

Device Class : 2

Duns Number: 963249342

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

FMwand - 00859729006127 Catalog Number : FM2121S

Device Description : FMwand Handpiece with Integrated Smoke Evacuation - 100 mm Length with 2 mm Diss FMwand Handpiece with Integrated Smoke Evacuation - 100 mm Length with 2 mm Dissecting Blade

Device Class : 2

Duns Number: 963249342

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

FMwand - 00859729006134 Catalog Number : FM2301S

Device Description : FMwand Handpiece with Integrated Smoke Evacuation - 150 mm Length with 2 mm Diss FMwand Handpiece with Integrated Smoke Evacuation - 150 mm Length with 2 mm Dissecting Loop

Device Class : 2

Duns Number: 963249342

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

FMwand - 00859729006141 Catalog Number : FM2302S

Device Description : FMwand Handpiece with Integrated Smoke Evacuation - 150 mm Length with 5 mm Resecting Loop

Device Class : 2

Duns Number: 963249342

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

FMsealer - 00859729006158 Catalog Number : FM3001

Device Description : FMsealer Open Shears

Device Class : 2

Duns Number: 963249342

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

FMsealer - 00859729006165 Catalog Number : FM4001

Device Description : FMsealer Laparoscopic Shears - 5 mm Diameter / 36 cm Length

Device Class : 2

Duns Number: 963249342

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

FMwand - 00859729006172 Catalog Number : FM2321S

Device Description : FMwand Handpiece with Integrated Smoke Evacuation - 150 mm Length with 2 mm Diss FMwand Handpiece with Integrated Smoke Evacuation - 150 mm Length with 2 mm Dissecting Blade

Device Class : 2

Duns Number: 963249342

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

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