DEVICE: Visi-Pro (00821684036396)
Device Identifier (DI) Information
Visi-Pro
PXB35-07-17-135
In Commercial Distribution
Covidien LP
PXB35-07-17-135
In Commercial Distribution
Covidien LP
Balloon-Expandable Biliary Stent System
Device Characteristics
Labeling does not contain MRI Safety Information | |
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. 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 |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
FGE | CATHETER, BILIARY, DIAGNOSTIC |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K061566 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Keep dry |
Clinically Relevant Size
[?]Size Type Text |
---|
Outer Diameter: 7 Millimeter |
Length: 17 Millimeter |
Catheter Gauge: 6 French |
Device Size Text, specify: Working Length,135,Centimeter; |
Device Record Status
0febaacb-7ef0-46ab-ac72-3e5529e158bc
February 15, 2024
6
October 16, 2015
February 15, 2024
6
October 16, 2015
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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(508)261-8000
covidien.udi@covidien.com
covidien.udi@covidien.com