DEVICE: LifeStent® XL Vascular & Biliary Stent (04049519001289)

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Device Identifier (DI) Information

LifeStent® XL Vascular & Biliary Stent
EX061203CS
EX061203CS
Bard Peripheral Vascular, Inc.
04049519001289
GS1
1
BARD® LIFESTENT® XL Vascular and Biliary Stent System 6 mm x 120 mm (130 cm delivery catheter)
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Device Characteristics

MR Conditional
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

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

GMDN Preferred Term Name GMDN 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.
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.
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FDA Product Code

[?]
Product Code Product Code Name
NIP STENT, SUPERFICIAL FEMORAL ARTERY
FGE CATHETER, BILIARY, DIAGNOSTIC
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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

[?]
Size Type Text
Device Size Text, specify: Implant Diameter,6 Millimeter
Device Size Text, specify: Catheter Length,130 Centimeter
Device Size Text, specify: Implant Length,120 Millimeter
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Device Status

In Commercial Distribution
September 17, 2014

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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(800)321-4254
medical.services@crbard.com
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