WALLSTENT™ Enteral Endoprosthesis

Basic Information

• Brand Name: WALLSTENT™ Enteral Endoprosthesis
• Primary DI: 08714729285052
• Version / Model: M00565560
• Company Name: BOSTON SCIENTIFIC CORPORATION
• Labeler DUNS: 021717889
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-09-24
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 41732854-e088-4434-b030-3750930a103e

Device Description

Colonic/Duodenal Stent with UNISTEP™ Plus Delivery 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
MQR	STENT, COLONIC, METALIC, EXPANDABLE	General, Plastic Surgery	878.3610	2
MUM	STENT,METALLIC,EXPANDABLE,DUODENAL	General, Plastic Surgery	878.3610	2

GMDN Terms

Code	Name	Definition	Implantable	Status
32640	Bare-metal duodenal stent	A sterile non-bioabsorbable tubular device intended to be implanted in the lumen of the duodenum for the palliative treatment of duodenal strictures caused by malignant neoplasms; it is typically used to help eliminate gastric outlet obstructions. It is typically a mesh structure made entirely of metal (e.g., high-grade stainless steel); it is typically expanded in situ (e.g., with a balloon catheter or self-expands) and disposable devices intended to assist implantation may be included.	Yes	Active
37847	Bare-metal colonic stent	A sterile non-bioabsorbable tubular device intended to be implanted in the lumen of the colon for the palliative treatment of colonic strictures caused by malignant neoplasms typically in the descending or sigmoid colon, or rectum. It is typically inserted and advanced to the site of implantation with a dedicated catheter, or other instrument, where it self-expands upon release. It is made of metal [e.g., stainless steel or metal alloy such as nickel-titanium alloy (Nitinol)] in a tubular mesh configuration, and is available in various sizes. It will typically be used to relieve large bowel obstruction prior to colectomy, or in patients having high operative risk and/or advanced disease.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08714729285052	GS1

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			20 mm Stent Diameter
Device Size Text, specify			60 mm Stent Length