HUMAN XTENSIONS LTD

Address:4 Meir Ariel St.,Netanya Central,IL

Want to know more about this Organization? Request more information now!

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

Laparoscope, General & Plastic Surgery (GCJ) (5) System, Surgical, Computer Controlled Instrument (NAY) (4) Electrosurgical, Cutting & Coagulation & Accessories (GEI) (1)

Premarket Exempt

Clear

HandX - 07290017376004 Catalog Number : 20-30-019-01

Device Description : The HandX is intended to assist in the accurate control of HX laparoscopic Instr The HandX is intended to assist in the accurate control of HX laparoscopic Instruments including needle holder and grasper, for endoscopic manipulation of tissue, including grasping, approximation, ligation, suturing, during laparoscopic surgical procedures. It is intended to be used by trained physicians in an operating room environment in accordance with its Instructions For Use.

Device Class : 2

Duns Number: 600165869

Premarket Exempt : No

Product Code : NAY, GCJ

Prescription Use : Yes

Device Count : 1

HandX Fenestrated Grasper 5mm - 07290017376011 Catalog Number : 20-30-015-01

Device Class : 2

Duns Number: 600165869

Premarket Exempt : No

Product Code : GCJ, NAY

Prescription Use : Yes

Device Count : 1

HandX Needle Holder 5mm - 07290017376028 Catalog Number : 20-30-014-01

Device Class : 2

Duns Number: 600165869

Premarket Exempt : No

Product Code : GCJ, NAY

Prescription Use : Yes

Device Count : 1

HandX Disposables - 07290017376035 Catalog Number : 20-30-009-01

Device Description : HandX Disposables include 1 Arc&Pads pouch and 1 DC Power Cable

Device Class : 2

Duns Number: 600165869

Premarket Exempt : No

Product Code : GCJ, NAY

Prescription Use : Yes

Device Count : 1

Monopolar Hook - 07290017376080 Catalog Number : 20-30-073-01

Device Description : The Monopolar Hook is a single-use sterile electrosurgical electrode for use wit The Monopolar Hook is a single-use sterile electrosurgical electrode for use with the HandXTM device. The Monopolar Hook is connected to the HandX device and transmits the HandX device motors’ rotation in order to articulate the movement of the end effector of the Monopolar Hook. It is designed to address surgeons’ needs relating to the application of monopolar diathermy for various surgical purposes.The Monopolar Hook is connected to a standard electrosurgical unit via a standard generator cable.

Device Class :

Duns Number: 600165869

Premarket Exempt : No

Product Code : GCJ, GEI

Prescription Use : Yes

Device Count : 1

Previous 1 Next