- Physicians Office Resource

BILIARY DRAINAGE TUBE SET - MAJ-449

Device Description

A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. It is made entirely of a synthetic polymer(s) [e.g., polytetrafluoroethylene (PTFE), polyethylene (PE), silicone] and may have various designs (e.g., continuous tube with or without drainage side holes, covered or non-covered mesh structure). Disposable devices intended to assist implantation may be included.

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

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 Identifiers

Device Id: 04953170047282

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: 14953170047289

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 04953170047282

Package Quantity: 1

Package Discontinue Date: 8/12/2022 12:00:00 AM

Package Status: Not in Commercial Distribution

Package Type: N/A

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