WallFlex™ Biliary Transhepatic

Basic Information

• Brand Name: WallFlex™ Biliary Transhepatic
• Primary DI: 08714729799429
• Version / Model: M00574640
• 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: 2020-08-20
• Public Version Status: Update
• Public Device Record Key: 44e3905f-181f-4981-9cad-f7e76207e68d

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
43695	Static magnetic lumbar spine orthosis	A body-support device containing or impregnated with magnetized metals or metallic compounds, designed to be worn around the hips to support the lower back (spine and coccyx) and produce a weak magnetic flux field that emanates from the surface of the lower back to assist the whole body’s innate healing capability to alleviate body aches and pains (e.g., from muscle soreness/stiffness, arthritis). This is a reusable device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08714729799429	GS1

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			80 mm Length
Device Size Text, specify			8 mm Diameter