DEVICE: E·Luminexx® Biliary Stent (04049519009872)

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Device Identifier (DI) Information

E·Luminexx® Biliary Stent
ZBL04060
ZBL04060
Bard Peripheral Vascular, Inc.
04049519009872
GS1
1
E·Luminexx® Biliary Stent 4 mm x 60 mm (135 cm delivery catheter)
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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
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.
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FDA Product Code

[?]
Product Code Product Code Name
FGE CATHETER, BILIARY, DIAGNOSTIC
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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
Special Storage Condition, Specify: Keep Away from Sunlight
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: Catheter Length, 135 Centimeter
Device Size Text, specify: Inner Diameter, 4 Millimeter
Device Size Text, specify: Stent Length, 60 Millimeter
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Device Status

In Commercial Distribution
July 14, 2015

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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
Yes
No CLOSE

Customer Contact

[?]
+1(800)321-4254
medical.services@crbard.com
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