Flexxus® Endoscopic Biliary Stent

Basic Information

• Brand Name: Flexxus® Endoscopic Biliary Stent
• Primary DI: 00801741099274
• Version / Model: LXB10040
• Catalog Number: LXB10040
• Company Name: Angiomed GmbH & Co. Medizintechnik KG
• Labeler DUNS: 320047483
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-02
• Public Version: 3
• Public Version Date: 2022-04-08
• Public Version Status: Update
• Public Device Record Key: 5ff1ee44-fc88-43f9-bee5-d27f7dee55dc

Device Description

Flexxus® Endoscopic Biliary Stent, 10 mm x 40 mm (190cm deployment 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 Safe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
43691	Bare-metal biliary stent	A non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency; it is not intended for vascular implantation. It may be a mesh structure or a continuous tube and is made entirely of metal [e.g., high-grade stainless steel, cobalt-chrome (Co-Cr), nickel-titanium alloy (Nitinol)]. It may be expandable in situ (e.g., with a balloon catheter or self-expands) and disposable devices intended to assist implantation may be included.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00801741099274	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Diameter, 10 Millimeter
Device Size Text, specify			Stent Length, 40 Millimeters
Device Size Text, specify			Deployment System, 190 Centimeters

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in a cool, dry, dark place.