Gastric Positioning System

Gastric Positioning System
GastriSail - GPS40

A thin, flexible, hollow cylinder with an inflatable balloon at the distal end designed to be inserted into a patient's stomach through the mouth and oesophagus to create and size a gastric pouch typically for a bariatric gastric surgical procedure (e.g., sleeve gastrectomy, gastric banding). The proximal end may include a check valve and connects to a syringe, typically included, intended to inflate the balloon to a predetermined volume; fluid suction/irrigation ports are provided at the distal end. This is a single-use device.

• Catheter Gauge: 40 French

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: KNT

Device Name: Tubes, Gastrointestinal (And Accessories)

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: GU

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 876.5980

Third Party Flag: N

Medical Specialty: GU

Device Id: 20884521517384

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 10884521517387

Package Quantity: 3

Package Discontinue Date: 3/25/2019 12:00:00 AM

Package Status: Not in Commercial Distribution

Package Type: CASE

Device Id: 10884521517387

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

Device Id: 10884521661516

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 20884521517384

Package Quantity: 3

Package Discontinue Date: 3/25/2019 12:00:00 AM

Package Status: Not in Commercial Distribution

Package Type: PACK