Traction Wire

Traction Wire
ProdiGI - ERD-TW35

A sterile, nonimplantable, intraoperative surgical instrument designed to be inserted into the abdominal or thoracic cavity through a compatible endoscopic instrument (e.g., an access port) to provide hands-free retraction of a selected organ by anchoring it to the cavity wall during a surgical intervention (e.g., gastroenterological, gynaecological and urological laparoscopic or thoracoscopic procedures). It is inserted using a dedicated applier and typically consists of two interconnected clips that clutch the tissue for anchoring to the cavity wall and grasping the organ. This is a single-use device.

• Length: 35 Millimeter

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: QSW

Device Name: Endoscopic Traction Device

Device Class: 2

Physical State: Traction device and system accessories

Definition: An endoscopic traction device is a prescription device that is endoscopically applied to retract tissue in the gastrointestinal tract during dissection procedures to increase visualization of the dissection plane and assist in tissue resection, exposure, and removal.

Submission Type ID: 1

Review Panel: GU

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Uses a traction device to grasp and retract tissue during endoscopic procedures

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Gastrointestinal tract

Regulation Number: 876.4410

Third Party Flag: N

Medical Specialty: GU

Device Id: 10884521806870

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A