WallFlex™ Biliary Transhepatic

Basic Information

• Brand Name: WallFlex™ Biliary Transhepatic
• Primary DI: 08714729820581
• Version / Model: M00574620
• Company Name: BOSTON SCIENTIFIC CORPORATION
• Labeler DUNS: 021717889
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 3
• Public Version Date: 2019-01-23
• Public Version Status: Update
• Public Device Record Key: 9facaf56-a9e0-4e6a-a925-7c799dde41b3

Device Description

Stent System

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FGE	CATHETER, BILIARY, DIAGNOSTIC	Gastroenterology, Urology	876.5010	2

GMDN Terms

Code	Name	Definition	Implantable	Status
43693	Multiple antifungal minimum inhibitory concentration (MIC) IVD, kit	A collection of reagents or test strips, and other associated materials, containing multiple antifungal/antimycotic agents (i.e., drugs intended for treatment and/or prevention of a fungal infection) at specified concentration gradients, that are intended to be used to determine the degree of susceptibility or the minimum inhibitory concentration (MIC) of a range of antifungal/antimycotic drugs, against a specific fungus or yeast, isolated by culture from a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08714729820581	GS1

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			40 mm Length
Device Size Text, specify			8 mm Diameter