DEVICE: EverFlex (00821684034323)

Device Identifier (DI) Information

EverFlex
PRB35-07-150-120
In Commercial Distribution
PRB35-07-150-120
Covidien LP
00821684034323
GS1

1
968903703 *Terms of Use
Self-Expanding Peripheral 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
Multiple peripheral artery stent, bare-metal A sterile non-bioabsorbable tubular device intended to be alternatively implanted in more than one peripheral artery (e.g., iliac, carotid, renal) to indefinitely maintain patency and improve luminal diameter in patients with atherosclerotic disease or following the recanalization of a total occlusion. It is typically implanted by a dedicated instrument where it self-expands upon release or is balloon expanded. It is made of metal [e.g., nickel-titanium alloy (Nitinol)] and may be a continuous tube of a certain length, a mesh structure, or other design for supporting constant blood flow through the artery. Some types may be used in the biliary duct as a secondary intended use.
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FDA Product Code

[?]
Product Code Product Code Name
NIP STENT, SUPERFICIAL FEMORAL ARTERY
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
P110023 004
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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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
Length: 150 Millimeter
Device Size Text, specify: Working Length,120,Centimeter;Compatible Guidewire,.035,Inch;Lumen Diameter,5.5 to 6.5,Millimeter;
Outer Diameter: 7 Millimeter
Catheter Gauge: 6 French
Outer Diameter: 2 Millimeter
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Device Record Status

15ec8306-657b-454e-9d1f-965a594fbb08
July 06, 2018
3
September 22, 2014
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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

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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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