DOMAIN SURGICAL, INC.

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) (10)

Premarket Exempt

No

Clear

FMX - 00859729006004 Catalog Number : FMG1

Device Description : FMX G1 Generator

Device Class : 2

Duns Number: 963249342

Premarket Exempt : No

Product Code : GEI

Prescription Use : No

Device Count : 1

FMX - 00859729006011 Catalog Number : FMDPM

Device Description : FMX Disposable Power Module

Device Class :

Duns Number: 963249342

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

FMX - 00859729006028 Catalog Number : FMRPM

Device Description : FMX Reusable Power Module

Device Class : 2

Duns Number: 963249342

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

FMX - 00859729006035 Catalog Number : FMG1FP

Device Description : FMX G1 Generator Foot Pedal

Device Class : 2

Duns Number: 963249342

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

FMwand - 00859729006059 Catalog Number : FM2101

Device Description : FMwand Handpiece - 100 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 - 00859729006066 Catalog Number : FM2102

Device Description : FMwand Handpiece - 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 - 00859729006073 Catalog Number : FM2121

Device Description : FMwand Handpiece - 100 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 - 00859729006080 Catalog Number : FM2301

Device Description : FMwand Handpiece - 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 - 00859729006097 Catalog Number : FM2302

Device Description : FMwand Handpiece - 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

FMwand - 00859729006103 Catalog Number : FM2101S

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 Loop

Device Class : 2

Duns Number: 963249342

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

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