BILIARY DRAINAGE TUBE SET - MAJ-348
Device Description
An invasive, flexible, tubular device intended to be used to manually push a biliary drainage catheter through the working channel of an endoscope and into position within the bile duct using a guidewire. The guidewire and catheter are not included with the pusher. This is a reusable device.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: True
Sterilization Methods:
- Moist Heat or Steam Sterilization
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
Device IdentifiersDevice Id: 04953170045929
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: 14953170045926
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 04953170045929
Package Quantity: 1
Package Discontinue Date: 8/12/2022 12:00:00 AM
Package Status: Not in Commercial Distribution
Package Type: N/A