DEVICE: LifeStent® Vascular & Biliary Stent (04049519001104)
Device Identifier (DI) Information
LifeStent® Vascular & Biliary Stent
EX070801CS
In Commercial Distribution
EX070801CS
Bard Peripheral Vascular, Inc.
EX070801CS
In Commercial Distribution
EX070801CS
Bard Peripheral Vascular, Inc.
BARD® LIFESTENT® Vascular and Biliary Stent System 7 mm x 80 mm (80 cm delivery catheter)
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 |
---|---|
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
[?]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 |
Sterilization
Storage and Handling
[?]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
[?]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
169ad0ce-8c5f-4dcd-8853-05e67733ba6b
March 29, 2018
2
September 17, 2014
March 29, 2018
2
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