DEVICE: LifeStent® Solo Vascular Stent (04049519004174)
Device Identifier (DI) Information
LifeStent® Solo Vascular Stent
EX071201CL
In Commercial Distribution
EX071201CL
Bard Peripheral Vascular, Inc.
EX071201CL
In Commercial Distribution
EX071201CL
Bard Peripheral Vascular, Inc.
LIFESTENT® SOLO™ Vascular Stent System 7 mm x 120 mm (80 cm delivery catheter)
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. 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 |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
NIP | STENT, SUPERFICIAL FEMORAL ARTERY |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Store in a cool, dry, dark place. |
Special Storage Condition, Specify: Keep away from sunlight |
Special Storage Condition, Specify: Keep dry |
Storage Environment Temperature: less than 60 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: Implant Diameter,7 Millimeter |
Device Size Text, specify: Catheter Length,80 Centimeter |
Device Size Text, specify: Implant Length,120 Millimeter |
Device Record Status
f07ce3a0-7b47-4500-8b99-848fdbcc98d6
February 03, 2023
5
September 17, 2014
February 03, 2023
5
September 17, 2014
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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)321-4254
medical.services@crbard.com
medical.services@crbard.com