Single Use Balloon Dilator V (with Knife) - BD-VC431Q-1840-25
Device Description
A flexible, multi-purpose, tubular device designed to be inserted into the duodenum via the oral cavity (cannulation) using a flexible endoscope to: 1) infuse contrast media; 2) deliver electrosurgical current in a monopolar configuration to cut the major duodenal papilla (papillotomy); and 3) balloon dilate the opening to the biliary tract, during endoscopic retrograde cholangiopancreatography (ERCP). It includes proximal controls, a distal monopolar electrosurgical cutting wire, an inflatable balloon and an inner lumen(s). It is intended to be used alongside separate devices designed for the removal of biliary stones. 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: KNS
Device Name: Unit, Electrosurgical, Endoscopic (With Or Without 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: 876.4300
Third Party Flag: Y
Medical Specialty: GU
Device IdentifiersDevice Id: 14953170373975
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 04953170373978
Package Quantity: 1
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: N/A
Device Id: 04953170373978
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