E-Luminexx® Vascular & Biliary Stent

Primary DI: 04049519009117
Brand: E-Luminexx® Vascular & Biliary Stent
Company: Bard Peripheral Vascular, Inc.
Model: ZBL08020
Catalog number: ZBL08020
Device description: Bard® E-LUMINEXX™ Vascular and Biliary Stent 8 mm x 20 mm (135 cm delivery catheter)
Published: 2014-09-19
Public version status: Update
Distribution status: In Commercial Distribution
MRI safety: MR Conditional
Rx: true
OTC: false
Sterile: true
Single use: true

Related Records

Contact Domains

crbard.com

Product Codes

Code	Name
NIO	STENT, ILIAC

Product Code Classifications

Code	Device	Specialty	Class
NIO	Stent, Iliac	Unknown	3

Identifiers And Packaging

Identifier	Type	Agency	Package quantity	Status
04049519009117	Primary	GS1	0

Alternate GTIN / UPC / EAN Codes

Source identifier	GTIN-14 normalized	EAN-13
04049519009117	04049519009117	4049519009117

GMDN Terms

Term	Definition
Bare-metal biliary stent	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 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.

Term

Definition

Bare-metal biliary stent

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 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.

Device Sizes

Type	Value	Unit
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0

Storage And Handling

Type	Low	High	Condition
Special Storage Condition, Specify	0	0	Keep away from sunlight
Special Storage Condition, Specify	0	0	Keep dry
Special Storage Condition, Specify	0	0	Store in a cool, dry, dark place.

Sterilization Methods

Method

Contacts

Phone	Email
+1(800)321-4254	medical.services@crbard.com

Regulatory Flags

DUNS number: 135057938
Device count: 1
DM exempt: false
Premarket exempt: false
HCT/P: false
Kit: false
Combination product: false
Lot or batch: true
Serial number: false
Manufacturing date on label: true
Expiration date on label: true
Donation ID number: false
Contains natural rubber latex: false
No natural rubber latex: false
Sterilization required before use: false

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