Fortimedix Surgical B.V.

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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

Laparoscope, General & Plastic Surgery (GCJ) (5) Laparoscopic Single Port Access Device (OTJ) (4)

Premarket Exempt

Clear

symphonX™ - 08719324463171 Catalog Number : 314-201

Device Description : Device for use in combination with the symphonX Introducer during minimally inva Device for use in combination with the symphonX Introducer during minimally invasive abdominal laparoscopic surgical procedures

Device Class : 2

Duns Number: 492888563

Premarket Exempt : No

Product Code : OTJ

Prescription Use : Yes

Device Count : 1

symphonX™ - 08719324463188 Catalog Number : 314-102

Device Description : The symphonX™ Introducer Clamp is to fix / snug fit lock the symphonX™ Introduce The symphonX™ Introducer Clamp is to fix / snug fit lock the symphonX™ Introducer to the trocar in axial direction during surgery.

Device Class : 2

Duns Number: 492888563

Premarket Exempt : No

Product Code : OTJ

Prescription Use : Yes

Device Count : 1

symphonX™ - 08719324463195 Catalog Number : 314-103

Device Description : The purpose of the symphonX™ Introducer Clamp is to fix / snug fit lock the symp The purpose of the symphonX™ Introducer Clamp is to fix / snug fit lock the symphonX™ Introducer to the trocar in axial direction during surgery.

Device Class : 2

Duns Number: 492888563

Premarket Exempt : No

Product Code : OTJ

Prescription Use : Yes

Device Count : 1

symphonX™ - 08719324463201 Catalog Number : 314-104

Device Class : 2

Duns Number: 492888563

Premarket Exempt : No

Product Code : OTJ

Prescription Use : Yes

Device Count : 1

symphonX™ - 08719324463317 Catalog Number : 314-007

Device Description : Device for grasping tissue; to be used in combination with the symphonX Handle, Device for grasping tissue; to be used in combination with the symphonX Handle, Handle with ratchet, Handle with on/off ratchet.

Device Class :

Duns Number: 492888563

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

symphonX™ - 08719324463324 Catalog Number : 314-008

Device Description : Device for grasping and dissecting tissue; to be used in combination with the sy Device for grasping and dissecting tissue; to be used in combination with the symphonX Handle, Handle with ratchet, Handle with on/off ratchet.

Device Class :

Duns Number: 492888563

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

symphonX™ - 08719324463331 Catalog Number : 314-009

Device Description : Device for cutting tissue; to be used in combination with the symphonX Handle, H Device for cutting tissue; to be used in combination with the symphonX Handle, Handle with ratchet, Handle with on/off ratchet.

Device Class :

Duns Number: 492888563

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

symphonX™ - 08719324463348 Catalog Number : 314-010

Device Description : Device for use as a delivery system for Hem-o-lok® ML Non-absorbable Polymer Lig Device for use as a delivery system for Hem-o-lok® ML Non-absorbable Polymer Ligation Clips; to be used in combination with the symphonX Handle, Handle with ratchet, Handle with on/off ratchet.

Device Class :

Duns Number: 492888563

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

symphonX™ - 08719324463355 Catalog Number : 314-011

Device Description : Device for cutting or coagulating tissue; to be used in combination with an elec Device for cutting or coagulating tissue; to be used in combination with an electrosurgical generator

Device Class :

Duns Number: 492888563

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

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