NC Gallant™ PTCA Catheter

GUDID 07290107011785

MEDINOL LTD.

Coronary angioplasty balloon catheter, basic
Primary Device ID07290107011785
NIH Device Record Key88660755-9eab-4cac-8d6b-6530c41fc821
Commercial Distribution StatusIn Commercial Distribution
Brand NameNC Gallant™ PTCA Catheter
Version Model NumberNCG250R30US
Company DUNS600593800
Company NameMEDINOL LTD.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
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
EmailCustomerService@medinol.com

Device Dimensions

Outer Diameter2.5 Millimeter
Outer Diameter2.5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS107290107011785 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LOXCatheters, Transluminal Coronary Angioplasty, Percutaneous

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 Date2017-02-03

On-Brand Devices [NC Gallant™ PTCA Catheter ]

07290107012263NCG500R20US
07290107012256NCG500R15US
07290107012249NCG500R12US
07290107012232NCG500R08US
07290107012225NCG500R06US
07290107012218NCG450R20US
07290107012201NCG450R15US
07290107012195NCG450R12US
07290107012188NCG450R08US
07290107012171NCG450R06US
07290107012164NCG400R30US
07290107012157NCG400R20US
07290107012140NCG400R15US
07290107012133NCG400R12US
07290107012126NCG400R08US
07290107012119NCG400R06US
07290107012102NCG375R30US
07290107012096NCG375R20US
07290107012089NCG375R15US
07290107012072NCG375R12US
07290107012065NCG375R08US
07290107012058NCG375R06US
07290107012041NCG350R30US
07290107012034NCG350R25US
07290107012027NCG350R20US
07290107012010NCG350R15US
07290107012003NCG350R12US
07290107011990NCG350R08US
07290107011983NCG350R06US
07290107011976NCG325R30US
07290107011969NCG325R20US
07290107011952NCG325R15US
07290107011945NCG325R12US
07290107011938NCG325R08US
07290107011921NCG325R06US
07290107011914NCG300R30US
07290107011907NCG300R25US
07290107011891NCG300R20US
07290107011884NCG300R15US
07290107011877NCG300R12US
07290107011860NCG300R08US
07290107011853NCG300R06US
07290107011846NCG275R30US
07290107011839NCG275R20US
07290107011822NCG275R15US
07290107011815NCG275R12US
07290107011808NCG275R08US
07290107011792NCG275R06US
07290107011785NCG250R30US
07290107011778NCG250R25US

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