DEVICE: LifeStent® Biliary Stent (04049519000619)
Device Identifier (DI) Information
LifeStent® Biliary Stent
EX100801CD
In Commercial Distribution
EX100801CD
Bard Peripheral Vascular, Inc.
EX100801CD
In Commercial Distribution
EX100801CD
Bard Peripheral Vascular, Inc.
Lifestent® Biliary Stent, 10mm x 80mm (80cm catheter length)
Device Characteristics
MR Conditional | |
No | |
No | |
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? |
---|---|---|---|---|
43691 | Bare-metal biliary stent |
A non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency; it is not intended for vascular implantation. 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.
|
Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
FGE | CATHETER, BILIARY, DIAGNOSTIC |
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: Keep Away from Sunlight |
Special Storage Condition, Specify: Keep Dry |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: Stent Length, 80 Millimeter |
Device Size Text, specify: Catheter Length, 80 Centimeter |
Device Size Text, specify: Inner Diameter, 10 Millimeter |
Device Record Status
7308f672-9b9e-49bf-abe5-68d4d9539ce5
January 04, 2024
4
July 13, 2015
January 04, 2024
4
July 13, 2015
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