Sutter Medizintechnik GmbH

Address:Alfred-Walz-Strasse 22,Emmendingen Baden-Wurttemberg,DE

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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 Yes

Clear

Sutter - ESUM360100010 Catalog Number : 360100-01

Device Description : RF-Generator CURIS® BM 1700 mono-/ bipolar RF-Generator CURIS® BM 1700 mono-/ bipolar incl. power cord, operating instruction,

Device Class : 2

Duns Number: 316625425

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Sutter - ESUM360100030 Catalog Number : 360100-03

Device Description : RF-Generator CURIS® BM 1700 mono-/ bipolar RF-Generator CURIS® BM 1700 mono-/ bipolar incl. power cord, operating instruction,

Device Class : 2

Duns Number: 316625425

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Sutter - ESUM3601100 Catalog Number : 360110

Device Description : Foot-switch, 2 pedals explosion proof, 4m cable Class IPX8

Device Class : 2

Duns Number: 316625425

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Sutter - ESUM3601140 Catalog Number : 360114

Device Description : Foot-switch, 2 pedals small explosion proof, 4m cable Class IPX8

Device Class : 2

Duns Number: 316625425

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Sutter - ESUM3601700 Catalog Number : 360170

Device Description : Monopolar cable 4.5m, 4mm instrument connector, female Monopolar cable 4.5m, 4mm instrument connector, female for Sutter BM-780 II, Martin,

Device Class : 2

Duns Number: 316625425

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Sutter - ESUM3601710 Catalog Number : 360171

Device Description : Monopolar cable 4.5m, 4mm instrument connector, female Monopolar cable 4.5m, 4mm instrument connector, female for ESU Valleylab, Conmed, Bovie, Bowa

Device Class : 2

Duns Number: 316625425

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Sutter - ESUM3601720 Catalog Number : 360172

Device Description : Monopolar cable 4.5m, 4mm instrument connector, female Monopolar cable 4.5m, 4mm instrument connector, female for Erbe ACC, Erbe ICC

Device Class : 2

Duns Number: 316625425

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Sutter - ESUM3601730 Catalog Number : 360173

Device Description : Monopolar cable 4.5m, 4mm instrument connector Monopolar cable 4.5m, 4mm instrument connector for 4mm connector, Erbe T-Serie

Device Class : 2

Duns Number: 316625425

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Sutter - ESUM360173180 Catalog Number : 360173-18

Device Description : Monopolar cable 1.8m, connector 4mm male/female

Device Class : 2

Duns Number: 316625425

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Sutter - ESUM360173300 Catalog Number : 360173-30

Device Description : Monopolar cable 3m, connector 4mm male/female

Device Class : 2

Duns Number: 316625425

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

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