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) (9) Laparoscopic Single Port Access Device (OTJ) (1)

Premarket Exempt

Clear

symphonX™ - 08719324463003 Catalog Number : 314-101

Device Description : The symphonX™ Introducer is intended to establish a path of entry for laparoscop The symphonX™ Introducer is intended to establish a path of entry for laparoscopic Instruments for use during minimally invasive abdominal laparoscopic surgery in combination with the symphonX™ (short) Instruments.

Device Class : 2

Duns Number: 492888563

Premarket Exempt : No

Product Code : OTJ

Prescription Use : Yes

Device Count : 1

symphonX™ - 08719324463089 Catalog Number : 314-301

Device Description : The symphonX™ Handle is for use in combination with the symphonX™ Instruments of The symphonX™ Handle is for use in combination with the symphonX™ Instruments of the types: Grasper (short), Maryland (short), Scissors (short) and Clip Applier (short).

Device Class : 2

Duns Number: 492888563

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

symphonX™ - 08719324463096 Catalog Number : 314-302

Device Description : The symphonX™ Handle with ratchet is for use in combination with the symphonX™ I The symphonX™ Handle with ratchet is for use in combination with the symphonX™ Instruments of the types: Grasper (short), Maryland (short), Scissors (short) and Clip Applier (short).

Device Class : 2

Duns Number: 492888563

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

symphonX™ - 08719324463102 Catalog Number : 314-303

Device Description : The symphonX™ Handle with on/off ratchet is for use in combination with the symp The symphonX™ Handle with on/off ratchet is for use in combination with the symphonX™ Instruments of the types: Grasper (short), Maryland (short), Scissors (short) and Clip Applier (short).

Device Class : 2

Duns Number: 492888563

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

symphonX™ - 08719324463119 Catalog Number : 314-001

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™ - 08719324463126 Catalog Number : 314-002

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 : 2

Duns Number: 492888563

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

symphonX™ - 08719324463133 Catalog Number : 314-003

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 : 2

Duns Number: 492888563

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

symphonX™ - 08719324463140 Catalog Number : 314-004

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 : 2

Duns Number: 492888563

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

symphonX™ - 08719324463157 Catalog Number : 314-005

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 : 2

Duns Number: 492888563

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

symphonX™ - 08719324463164 Catalog Number : 314-006

Device Description : Device for irrigating/ aspirating

Device Class : 2

Duns Number: 492888563

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

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