NC SPRINTER®

GUDID 00643169282131

BALLOON NCSP4021X NCSPRINTER RX M US

MEDTRONIC, INC.

Coronary angioplasty balloon catheter, basic
Primary Device ID00643169282131
NIH Device Record Key0980ae57-77be-4c27-a82d-77350f84c012
Commercial Distribution StatusIn Commercial Distribution
Brand NameNC SPRINTER®
Version Model NumberNCSP4021X
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
GS100643169282131 [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 Date2016-04-17

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