DEVICE: NIRxcell CoCr Coronary Stent on RX System (07290107011051)

Download: XML | JSON

Device Identifier (DI) Information

NIRxcell CoCr Coronary Stent on RX System
NXL40028US

MEDINOL LTD.
07290107011051
GS1
1
No description.
CLOSE

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).
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
MAF Stent, Coronary
CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Store in a cool, dark, dry place
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Length: 28 Millimeter
Outer Diameter: 4.0 Millimeter
CLOSE

Device Status

In Commercial Distribution
October 01, 2014

CLOSE

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
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
1-800-477-5801
xxx@xxx.xxx
CLOSE