Single Use 3-Lumen Extraction Balloon V

Single Use 3
Single Use 3-Lumen Extraction Balloon V - B-V231P-B

A flexible, tubular, non-electrical device with an inflatable multi-sizing balloon at the distal end designed for the removal of stones (calculi) from the biliary tract during endoscopic retrograde cholangiopancreatography (ERCP). It is inserted through the working channel of an endoscope, typically beyond the stones, where the balloon is inflated and retracted to push the stones out. It typically has more than one lumen to allow, e.g., use of a guidewire while simultaneously enabling the injection of a contrast medium into the biliary tree for fluoroscopic visualization of the bile ducts. This is a single-use device.

No Data Available

No Data Available

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: FGE

Device Name: Stents, Drains And Dilators For The Biliary Ducts

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: Y

Unclassified Reason: N/A

Implant Flag: Y

Target Area: N/A

Regulation Number: 876.5010

Third Party Flag: N

Medical Specialty: GU

Device Id: 14953170183451

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 04953170183454

Package Quantity: 1

Package Discontinue Date: 8/10/2022 12:00:00 AM

Package Status: Not in Commercial Distribution

Package Type: N/A

Device Id: 04953170183454

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