NIRxcell™ CoCr Coronary Stent on RX System

GUDID 07290107012973

MEDINOL LTD.

Bare-metal coronary artery stent
Primary Device ID07290107012973
NIH Device Record Key9fa9d53c-74ae-4995-b457-3df8f1e01bd2
Commercial Distribution StatusIn Commercial Distribution
Brand NameNIRxcell™ CoCr Coronary Stent on RX System
Version Model NumberNXL35015US
Company DUNS600593800
Company NameMEDINOL LTD.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-477-5801
Emailxxx@xxx.xxx

Device Dimensions

Outer Diameter3.5 Millimeter
Outer Diameter3.5 Millimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dark, dry place

Device Identifiers

Device Issuing AgencyDevice ID
GS107290107012973 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAFStent, Coronary

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-10-07
Device Publish Date2017-05-09

On-Brand Devices [NIRxcell™ CoCr Coronary Stent on RX System]

07290107012980NXL40015US
07290107012973NXL35015US
07290107012966NXL30015US
07290107012959NXL27515US
07290107012942NXL25015US
07290107010757NXL25008US

Trademark Results [NIRxcell]

Mark Image

Registration | Serial
Company
Trademark
Application Date
NIRXCELL
NIRXCELL
85824313 4712927 Live/Registered
Medinol Ltd.
2013-01-16

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