DEVICE: Visi-Pro (00821684036396)

Device Identifier (DI) Information

Visi-Pro
PXB35-07-17-135
In Commercial Distribution
PXB35-07-17-135
Covidien LP
00821684036396
GS1

1
968903703 *Terms of Use
Balloon-Expandable Biliary Stent System
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Bare-metal biliary stent A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. 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.
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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 [?]
K061566 000
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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;AVOID DIRECT SUNLIGHT
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Clinically Relevant Size

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Size Type Text
Outer Diameter: 7 Millimeter
Length: 17 Millimeter
Catheter Gauge: 6 French
Device Size Text, specify: Working Length,135,Centimeter;
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Device Record Status

0febaacb-7ef0-46ab-ac72-3e5529e158bc
July 06, 2018
3
October 16, 2015
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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

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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
No
No CLOSE

Customer Contact

[?]
+1(508)261-8000
covidien.udi@covidien.com
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