DEVICE: LifeStent® Solo Vascular Stent (04049519004303)

Device Identifier (DI) Information

LifeStent® Solo Vascular Stent
EX062003CL
In Commercial Distribution
EX062003CL
Bard Peripheral Vascular, Inc.
04049519004303
GS1

1
135057938 *Terms of Use
LIFESTENT® SOLO™ Vascular Stent System 6 mm x 200 mm (135 cm delivery catheter)
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Device Characteristics

MR Conditional
No
Yes
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
47932 Peripheral artery stent, bare-metal
A non-bioabsorbable tubular device intended to be implanted in a peripheral artery (excludes aorta, coronary, and intracranial arteries) to indefinitely maintain patency and improve luminal diameter in patients with atherosclerotic disease, or following the recanalization of a total occlusion. It may additionally be intended to be implanted in an obstructed biliary duct; it is not dedicated to carotid artery implantation. The stent is made entirely of metal [e.g., nickel-titanium alloy (Nitinol) mesh structure] and is typically implanted by a dedicated instrument where it self-expands upon release or is balloon expanded.
Active true
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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 dry
Storage Environment Temperature: less than 60 Degrees Celsius
Special Storage Condition, Specify: Store in a cool, dry, dark place.
Special Storage Condition, Specify: Keep away from sunlight
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: Implant Diameter,6 Millimeter
Device Size Text, specify: Implant Length,200 Millimeter
Device Size Text, specify: Catheter Length,135 Centimeter
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Device Record Status

6570e99f-8fea-426b-aa2d-7856629d414b
February 03, 2023
5
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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