- Physicians Office Resource

Single Use Stent Insertion Kit V - MAJ-1818

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 Identifiers

Device Id: 14953170347389

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 04953170347382

Package Quantity: 1

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: N/A

Device Id: 04953170347382

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

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