DEVICE: NIRxcell CoCr Coronary Stent on RX System (07290107010900)
Device Identifier (DI) Information
NIRxcell CoCr Coronary Stent on RX System
NXL30024US
In Commercial Distribution
MEDINOL LTD.
NXL30024US
In Commercial Distribution
MEDINOL LTD.
No description.
Device Characteristics
MR Conditional | |
No | |
Yes | |
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 coronary artery stent | A sterile non-bioabsorbable tubular device [bare metal stent (BMS)] intended to be implanted in a coronary artery or saphenous vein graft of the heart to maintain luminal patency and improve luminal diameter typically in a patient with symptomatic atherosclerotic heart disease. It may be inserted and advanced to the implantation site with a balloon catheter which will cause the device to expand upon balloon inflation, or it may be delivered by a dedicated instrument where it self-expands upon release. It is typically made of high-grade stainless steel or cobalt-chrome (Co-Cr). It may be a continuous tube, a mesh structure, or have a bifurcation design (e.g., shaped as a Y in a tube form). |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MAF | Stent, Coronary |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
P110004 | 001 |
P110004 | 002 |
P110004 | 018 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Store in a cool, dark, dry place |
Clinically Relevant Size
[?]Size Type Text |
---|
Length: 24 Millimeter |
Outer Diameter: 3.0 Millimeter |
Device Record Status
3d5343ac-bdda-4825-977d-2c536e0f5ce5
July 06, 2018
3
October 01, 2014
July 06, 2018
3
October 01, 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 |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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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
[?]
1-800-477-5801
xxx@xxx.xxx
xxx@xxx.xxx