DEVICE: EluNIRTM Ridaforolimus Eluting Coronary Stent System (07290107016704)

Device Identifier (DI) Information

EluNIRTM Ridaforolimus Eluting Coronary Stent System
LUN225L17US
Not in Commercial Distribution

MEDINOL LTD.
07290107016704
GS1
April 16, 2024
1
600593800 *Terms of Use
No description.
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Device Characteristics

MR Conditional
No
Yes
Yes
Yes
No
No
Yes
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?
56284 Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated
A non-bioabsorbable metal tubular mesh structure covered with a non-bioabsorbable polymer and a drug coating that is designed to be implanted, via a delivery catheter, into a coronary artery (or saphenous vein graft) to maintain its patency typically in a patient with symptomatic atherosclerotic heart disease. The drug coating is slowly released and intended to inhibit restenosis by reducing vessel smooth muscle cell proliferation. Disposable devices associated with implantation may be included.
Active true
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FDA Product Code

[?]
Product Code Product Code Name
NIQ Coronary Drug-Eluting Stent
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
P170008 038
No CLOSE

Sterilization

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

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
Stent Diameter: 2.25 Millimeter
Stent Length: 17 Millimeter
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Device Record Status

75f7ff35-46ed-49e1-8745-b2c7a68f1454
September 25, 2024
2
October 20, 2022
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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
No
No CLOSE

Customer Contact

[?]
(720) 386 5585
customerservice@medinol.com
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