DEVICE: Flair® Endovascular Stent Graft (04049519008813)

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Device Identifier (DI) Information

Flair® Endovascular Stent Graft
FAF08030
FAF08030
Bard Peripheral Vascular, Inc.
04049519008813
GS1
1
FLAIR® Endovascular Stent Graft 8 mm x 30 mm (80 cm delivery catheter)(flared)
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Device Characteristics

MR Conditional
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
Iliofemoral artery endovascular stent-graft A sterile non-bioabsorbable tubular device intended to be implanted in the iliac and, alternatively, superficial femoral arteries to reline tortuous arteries in patients with symptomatic peripheral vascular disease (PVD). It is percutaneously inserted via the femoral artery to the site of implantation, with a disposable delivery device, where it self-expands. It is typically made of nickel-titanium alloy (Nitinol) that forms an outer mesh structure with an inner polymer tube (endovascular graft). It is available in a variety of lengths and diameters. Disposable devices associated with implantation may be included.
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FDA Product Code

[?]
Product Code Product Code Name
MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
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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: Protect the packaged product from direct sunlight
Special Storage Condition, Specify: Keep dry
Special Storage Condition, Specify: Keep away from sunlight
Special Storage Condition, Specify: Store in a cool (room temperature), dry place
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: Implant Diameter,8 Millimeter
Device Size Text, specify: Catheter Length,80 Centimeter
Device Size Text, specify: Implant Length,30 Millimeter
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Device Status

In Commercial Distribution
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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