DEVICE: E-Luminexx® Vascular & Biliary Stent (04049519009148)

Device Identifier (DI) Information

E-Luminexx® Vascular & Biliary Stent
ZBL08060
In Commercial Distribution
ZBL08060
Bard Peripheral Vascular, Inc.
04049519009148
GS1

1
135057938 *Terms of Use
Bard® E-LUMINEXX™ Vascular and Biliary Stent 8 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© 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?
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
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
NIO STENT, ILIAC
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: Store in a cool, dry, dark place.
Special Storage Condition, Specify: Keep away from sunlight
Special Storage Condition, Specify: Keep dry
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: Implant Length,60 Millimeter
Device Size Text, specify: Catheter Length,135 Centimeter
Device Size Text, specify: Implant Diameter,8 Millimeter
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Device Record Status

b0da5e7a-14e0-4085-948d-163b586ae38e
February 03, 2023
6
September 19, 2014
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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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