DEVICE: NIRxcell CoCr Coronary Stent on RX System (07290107010917)
Device Identifier (DI) Information
NIRxcell CoCr Coronary Stent on RX System
NXL30028US
In Commercial Distribution
MEDINOL LTD.
NXL30028US
In Commercial Distribution
MEDINOL LTD.
No description.
Device Characteristics
MR Conditional | |
No | |
Yes | |
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? |
---|---|---|---|---|
53616 | Bare-metal coronary artery stent |
A 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 is typically made of high-grade stainless steel or cobalt-chrome (Co-Cr), may be linear or have a bifurcation design (e.g., shaped as a Y in a tube form), and may be balloon-expanded or self-expandable. Dedicated disposable implantation devices (e.g., balloon catheter, delivery instrument) may be included.
|
Active | true |
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: 28 Millimeter |
Outer Diameter: 3.0 Millimeter |
Device Record Status
3365f4ce-eb3a-406f-9e9f-d45e322184e2
October 07, 2019
4
July 22, 2015
October 07, 2019
4
July 22, 2015
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 |
---|---|
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