FDA UDI
Not in Commercial Distribution
🇺🇸 United States
E-Luminexx® Biliary Stent
DI: 04049519009971
·
Model: ZBL05120
·
Bard Peripheral Vascular, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- E-Luminexx® Biliary Stent
- Primary DI
- 04049519009971
- Version / Model
- ZBL05120
- Catalog Number
- ZBL05120
- Company Name
- Bard Peripheral Vascular, Inc.
- Labeler DUNS
- 135057938
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-07-14
- Public Version
- 4
- Public Version Date
- 2024-04-22
- Public Version Status
- Update
- Public Device Record Key
- 94af9ea5-57ba-4037-8d5f-21dbc8f9a8ee
- Distribution End Date
- 2023-04-12
Device Description
E-Luminexx® Biliary Stent 5 mm x 120 mm (135 cm delivery catheter)
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FGE | CATHETER, BILIARY, DIAGNOSTIC | Gastroenterology, Urology | 876.5010 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04049519009971 | GS1 |
Customer Contacts
- Phone
- +1(800)321-4254
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Stent Length, 120 Millimeter | ||
| Device Size Text, specify | Catheter Length, 135 Centimeter | ||
| Device Size Text, specify | Inner Diameter, 5 Millimeter |