Single Use Stent Insertion Kit V - MAJ-1821
Device Description
An assembly of sterile devices inserted through a compatible flexible endoscope to implant a stent, typically into a pancreatic or biliary duct in order to maintain patency. It typically consists of a positioning catheter onto which the stent is loaded, a guiding device (commonly known as an introducer or guidewire) that aids the initial placement of the stent, and a pusher catheter that holds the stent in place during withdrawal of the other component devices. It is commonly made of polytetrafluoroethylene (PTFE) [Teflon], or polyethylene (PE). 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: QGE
Device Name: Biliary Stent, Drain, And Dilator Accessories
Device Class: 1
Physical State: Guiding catheter, pushing catheter, pigtail straightener, flap protector, nasal transfer tube, and drainage connecting tube
Definition: Biliary stent, drain, and dilator accessories are manual devices that aid in the introduction and connection of biliary stents, drains, or dilators. This generic type of device includes the guiding catheter, pushing catheter, pigtail straightener, flap protector, nasal transfer tube, and drainage connecting tube.
Submission Type ID: 4
Review Panel: GU
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: The accessories identified are used for the placement of biliary stents, drains, and dilators.
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: Bile duct
Regulation Number: 876.5012
Third Party Flag: N
Medical Specialty: GU
Device IdentifiersDevice Id: 14953170347419
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 04953170347412
Package Quantity: 1
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: N/A
Device Id: 04953170347412
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