Single Use 3-Lumen Extraction Balloon V - B-V443Q-B
Device Description
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.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
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
Code: LQR
Device Name: Dislodger, Stone, Biliary
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: 876.5010
Third Party Flag: Y
Medical Specialty: GU
Device IdentifiersDevice Id: 14953170368773
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 04953170368776
Package Quantity: 1
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: N/A
Device Id: 04953170368776
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: 54953170368771
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 14953170368773
Package Quantity: 15
Package Discontinue Date: 8/25/2023 12:00:00 AM
Package Status: Not in Commercial Distribution
Package Type: N/A