AccessGUDID - DEVICE: NIRxcell CoCr Coronary Stent on RX System (07290107010849)

GUDID

Device Identifier (DI) Information

Brand Name: NIRxcell CoCr Coronary Stent on RX System
Version or Model: NXL27528US
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MEDINOL LTD.

Primary DI Number: 07290107010849
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

[?]

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

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

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 28 Millimeter
Outer Diameter: 2.75 Millimeter

Device Record Status

Public Device Record Key: 32dfba08-4a39-4f79-b6ba-77e70e5e2825
Public Version Date: October 07, 2019
Public Version Number: 4
DI Record Publish Date: October 01, 2014