AccessGUDID - DEVICE: LifeStent® Vascular & Biliary Stent (04049519001104)

GUDID

Device Identifier (DI) Information

Brand Name: LifeStent® Vascular & Biliary Stent
Version or Model: EX070801CS
Commercial Distribution Status: In Commercial Distribution
Catalog Number: EX070801CS
Company Name: Bard Peripheral Vascular, Inc.

Primary DI Number: 04049519001104
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 135057938 *Terms of Use

Device Description: BARD® LIFESTENT® Vascular and Biliary Stent System 7 mm x 80 mm (80 cm delivery catheter)

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Multiple peripheral artery stent, bare-metal	A sterile non-bioabsorbable tubular device intended to be alternatively implanted in more than one peripheral artery (e.g., iliac, carotid, renal) to indefinitely maintain patency and improve luminal diameter in patients with atherosclerotic disease or following the recanalization of a total occlusion. It is typically implanted by a dedicated instrument where it self-expands upon release or is balloon expanded. It is made of metal [e.g., nickel-titanium alloy (Nitinol)] and may be a continuous tube of a certain length, a mesh structure, or other design for supporting constant blood flow through the artery. Some types may be used in the biliary duct as a secondary intended use.
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.

GMDN Preferred Term Name

GMDN Definition

Multiple peripheral artery stent, bare-metal

A sterile non-bioabsorbable tubular device intended to be alternatively implanted in more than one peripheral artery (e.g., iliac, carotid, renal) to indefinitely maintain patency and improve luminal diameter in patients with atherosclerotic disease or following the recanalization of a total occlusion. It is typically implanted by a dedicated instrument where it self-expands upon release or is balloon expanded. It is made of metal [e.g., nickel-titanium alloy (Nitinol)] and may be a continuous tube of a certain length, a mesh structure, or other design for supporting constant blood flow through the artery. Some types may be used in the biliary duct as a secondary intended use.

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.

FDA Product Code

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Product Code	Product Code Name
FGE	CATHETER, BILIARY, DIAGNOSTIC
NIP	STENT, SUPERFICIAL FEMORAL ARTERY

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

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Storage and Handling
Special Storage Condition, Specify: Store in a cool, dry, dark place.
Special Storage Condition, Specify: Keep dry
Storage Environment Temperature: less than 60 Degrees Celsius
Special Storage Condition, Specify: Keep away from sunlight

Clinically Relevant Size

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Size Type Text
Device Size Text, specify: Implant Length,80 Millimeter
Device Size Text, specify: Implant Diameter,7 Millimeter
Device Size Text, specify: Catheter Length,80 Centimeter

Device Record Status

Public Device Record Key: 169ad0ce-8c5f-4dcd-8853-05e67733ba6b
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 17, 2014