DEVICE: E·Luminexx® Biliary Stent (04049519010311)

Device Identifier (DI) Information

E·Luminexx® Biliary Stent
ZBM08120
In Commercial Distribution
ZBM08120
Bard Peripheral Vascular, Inc.
04049519010311
GS1

1
135057938 *Terms of Use
E·Luminexx® Biliary Stent 8 mm x 120 mm (80 cm delivery catheter)
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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
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FDA Product Code

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

[?]
Size Type Text
Device Size Text, specify: Stent Length, 120 Millimeter
Device Size Text, specify: Catheter Length, 80 Centimeter
Device Size Text, specify: Inner Diameter, 8 Millimeter
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Device Record Status

8b7c79ca-1536-4fce-af16-669a9c9e7294
April 08, 2022
3
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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