AccessGUDID - DEVICE: E·Luminexx® Biliary Stent (04049519010205)

GUDID

Device Identifier (DI) Information

Brand Name: E·Luminexx® Biliary Stent
Version or Model: ZBL14080
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ZBL14080
Company Name: Bard Peripheral Vascular, Inc.

Primary DI Number: 04049519010205
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 135057938 *Terms of Use

Device Description: E·Luminexx® Biliary Stent 14 mm x 80 mm (135 cm delivery catheter)

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

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: Catheter Length, 135 Centimeter
Device Size Text, specify: Stent Length, 80 Millimeter
Device Size Text, specify: Inner Diameter, 14 Millimeter

Device Record Status

Public Device Record Key: 9c1e5c02-123e-4178-944e-62c7cf7abf3b
Public Version Date: April 08, 2022
Public Version Number: 3
DI Record Publish Date: July 14, 2015