NIRxcell CoCr Coronary Stent on RX System

GUDID 07290107010948

MEDINOL LTD.

Bare-metal coronary artery stent
Primary Device ID07290107010948
NIH Device Record Key64bbad99-f82c-4f66-a292-4a31d06261fa
Commercial Distribution StatusIn Commercial Distribution
Brand NameNIRxcell CoCr Coronary Stent on RX System
Version Model NumberNXL35012US
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
GS107290107010948 [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 Date2014-10-01

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

07290107011068NXL40033US
07290107011051NXL40028US
07290107011044NXL40024US
07290107011037NXL40020US
07290107011020NXL40017US
07290107011013NXL40012US
07290107011006NXL40008US
07290107010993NXL35033US
07290107010986NXL35028US
07290107010979NXL35024US
07290107010962NXL35020US
07290107010955NXL35017US
07290107010948NXL35012US
07290107010931NXL35008US
07290107010924NXL30033US
07290107010917NXL30028US
07290107010900NXL30024US
07290107010894NXL30020US
07290107010887NXL30017US
07290107010870NXL30012US
07290107010863NXL30008US
07290107010856NXL27533US
07290107010849NXL27528US
07290107010832NXL27524US
07290107010825NXL27520US
07290107010818NXL27517US
07290107010801NXL27512US
07290107010795NXL27508US
07290107010788NXL25020US
07290107010771NXL25017US
07290107010764NXL25012US

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