DEVICE: Flair® Endovascular Stent Graft (04049519008868)
Device Identifier (DI) Information
Flair® Endovascular Stent Graft
FAF09040
Not in Commercial Distribution
FAF09040
Bard Peripheral Vascular, Inc.
FAF09040
Not in Commercial Distribution
FAF09040
Bard Peripheral Vascular, Inc.
FLAIR® Endovascular Stent Graft 9 mm x 40 mm (80 cm delivery catheter)(flared)
Device Characteristics
MR Conditional | |
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? |
---|---|---|---|---|
43526 | Peripheral artery endovascular stent-graft, non-medicated |
A non-bioabsorbable tubular device intended to be implanted in a peripheral artery (excludes coronary and intracranial arteries) to maintain patency and improve luminal diameter, typically in patients with symptomatic peripheral vascular disease or following the recanalization of a total occlusion; it may in addition be intended for optional venous implantation. It does not include anticoagulant or antiproliferative pharmaceuticals. It is a metallic outer mesh-like structure with an inner synthetic polymer tube (endovascular graft) available in various sizes. It is percutaneously inserted with a disposable delivery device which may be included with the stent-graft.
|
Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
PFV | System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
P060002 | 000 |
P060002 | 001 |
P060002 | 002 |
P060002 | 006 |
P060002 | 011 |
P060002 | 034 |
P060002 | 038 |
Sterilization
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 |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: Implant Diameter,9 Millimeter |
Device Size Text, specify: Catheter Length,80 Centimeter |
Device Size Text, specify: Implant Length,40 Millimeter |
Device Record Status
c48c2f96-fad9-4e0d-98bb-eb9cccf39aa3
February 03, 2023
8
September 19, 2014
February 03, 2023
8
September 19, 2014
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
14049519008865 | 1 | 04049519008868 | 2022-05-10 | Not in Commercial Distribution | Other |
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(800)321-4254
medical.services@crbard.com
medical.services@crbard.com