AccessGUDID - DEVICE: NIRxcell CoCr Coronary Stent on RX System (07290107010900)

GUDID

Device Identifier (DI) Information

Brand Name: NIRxcell CoCr Coronary Stent on RX System
Version or Model: NXL30024US
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MEDINOL LTD.

Primary DI Number: 07290107010900
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 600593800 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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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).

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

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Product Code	Product Code Name
MAF	Stent, Coronary

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P110004	001
P110004	002
P110004	018

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

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Storage and Handling
Special Storage Condition, Specify: Store in a cool, dark, dry place

Clinically Relevant Size

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Size Type Text
Length: 24 Millimeter
Outer Diameter: 3.0 Millimeter

Device Record Status

Public Device Record Key: 3d5343ac-bdda-4825-977d-2c536e0f5ce5
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: October 01, 2014