Gastric Positioning System
GastriSail - GPS36
Device Description
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.
Environmental Conditions
- No;
- 1060.00
- 500.00
Device Sizes
- Outer Diameter: 36 Millimeter
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
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 Identifiers
Device Id: 20884521517377
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 10884521517370
Package Quantity: 3
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: CASE
Device Id: 10884521517370
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: 10884521661509
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 10884521517370
Package Quantity: 9
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: PACK_OR_INNER_PACK
