NC Euphora™

GUDID 00643169396234

BALLOON NCEUP4008X NCEUPHORA RX US

MEDTRONIC, INC.

Coronary angioplasty balloon catheter, basic
Primary Device ID00643169396234
NIH Device Record Key118f621d-c449-4d91-b7f4-7bdaab80079c
Commercial Distribution StatusIn Commercial Distribution
Brand NameNC Euphora™
Version Model NumberNCEUP4008X
Company DUNS006261481
Company NameMEDTRONIC, INC.
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Device Dimensions

Outer Diameter4 Millimeter
Outer Diameter4 Millimeter
Outer Diameter4 Millimeter
Outer Diameter4 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169396234 [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 Date2016-04-21

On-Brand Devices [NC Euphora™]

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00643169396708BALLOON NCEUP2008X NCEUPHORA RX US
00643169396692BALLOON NCEUP2012X NCEUPHORA RX US
00643169396685BALLOON NCEUP2015X NCEUPHORA RX US
00643169396678BALLOON NCEUP2020X NCEUPHORA RX US
00643169396661BALLOON NCEUP22506X NCEUPHORA RX US
00643169396357BALLOON NCEUP3508X NCEUPHORA RX US
00643169396340BALLOON NCEUP3512X NCEUPHORA RX US
00643169396333BALLOON NCEUP3515X NCEUPHORA RX US
00643169396326BALLOON NCEUP3520X NCEUPHORA RX US
00643169396319BALLOON NCEUP3527X NCEUPHORA RX US
00643169396302BALLOON NCEUP37506X NCEUPHORA RX US
00643169396296BALLOON NCEUP37508X NCEUPHORA RX US
00643169396289BALLOON NCEUP37512X NCEUPHORA RX US
00643169396272BALLOON NCEUP37515X NCEUPHORA RX US
00643169396265BALLOON NCEUP37520X NCEUPHORA RX US
00643169396258BALLOON NCEUP37527X NCEUPHORA RX US
00643169396241BALLOON NCEUP4006X NCEUPHORA RX US
00643169396234BALLOON NCEUP4008X NCEUPHORA RX US
00643169396227BALLOON NCEUP4012X NCEUPHORA RX US
00643169396210BALLOON NCEUP4015X NCEUPHORA RX US
00643169396203BALLOON NCEUP4020X NCEUPHORA RX US
00643169396197BALLOON NCEUP4027X NCEUPHORA RX US
00643169396180BALLOON NCEUP4508X NCEUPHORA RX US
00643169396173BALLOON NCEUP4512X NCEUPHORA RX US
00643169396166BALLOON NCEUP4515X NCEUPHORA RX US
00643169396159BALLOON NCEUP2515X NCEUPHORA RX US
00643169396142BALLOON NCEUP2520X NCEUPHORA RX US
00643169396135BALLOON NCEUP2527X NCEUPHORA RX US
00643169396128BALLOON NCEUP27506X NCEUPHORA RX US
00643169396111BALLOON NCEUP27508X NCEUPHORA RX US
00643169396104BALLOON NCEUP5012X NCEUPHORA RX US
00643169396098BALLOON NCEUP5015X NCEUPHORA RX US
00643169396081BALLOON NCEUP4520X NCEUPHORA RX US
00643169396074BALLOON NCEUP5008X NCEUPHORA RX US
00643169396067BALLOON NCEUP3506X NCEUPHORA RX US
00643169396050BALLOON NCEUP22508X NCEUPHORA RX US
00643169396043BALLOON NCEUP22512X NCEUPHORA RX US
00643169396036BALLOON NCEUP22515X NCEUPHORA RX US
00643169396029BALLOON NCEUP22520X NCEUPHORA RX US
00643169395954BALLOON NCEUP2506X NCEUPHORA RX US
00643169395947BALLOON NCEUP2508X NCEUPHORA RX US
00643169395930BALLOON NCEUP2512X NCEUPHORA RX US
00643169395923BALLOON NCEUP27512X NCEUPHORA RX US
00643169395916BALLOON NCEUP27515X NCEUPHORA RX US
00643169395909BALLOON NCEUP27520X NCEUPHORA RX US
00643169395893BALLOON NCEUP27527X NCEUPHORA RX US
00643169395886BALLOON NCEUP3006X NCEUPHORA RX US
00643169395879BALLOON NCEUP3008X NCEUPHORA RX US
00643169395862BALLOON NCEUP3012X NCEUPHORA RX US
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