DEVICE: LifeStent® Solo Vascular Stent (04049519004266)

Device Identifier (DI) Information

LifeStent® Solo Vascular Stent
EX061003CL
In Commercial Distribution
EX061003CL
Bard Peripheral Vascular, Inc.
04049519004266
GS1

1
135057938 *Terms of Use
LIFESTENT® SOLO™ Vascular Stent System 6 mm x 100 mm (135 cm delivery catheter)
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Device Characteristics

MR Conditional
No
Yes
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
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
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

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: Keep dry
Special Storage Condition, Specify: Store in a cool, dry, dark place.
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: Implant Diameter,6 Millimeter
Device Size Text, specify: Implant Length,100 Millimeter
Device Size Text, specify: Catheter Length,135 Centimeter
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Device Record Status

0921ee82-eb73-4764-b9b8-e87c719f42d9
March 29, 2018
2
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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