NC SPRINTER®

GUDID 00643169281998

BALLOON NCSP3509X NCSPRINTER RX M US

MEDTRONIC, INC.

Coronary angioplasty balloon catheter, basic
Primary Device ID00643169281998
NIH Device Record Keyc5730778-3258-405e-9545-b0b7076e08be
Commercial Distribution StatusIn Commercial Distribution
Brand NameNC SPRINTER®
Version Model NumberNCSP3509X
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

Length9 Millimeter
Length9 Millimeter
Length9 Millimeter
Length9 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169281998 [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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00643169282094BALLOON NCSP4006X NCSPRINTER RX M US
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00643169282070BALLOON NCSP37515X NCSPRINTER RX M US
00643169282063BALLOON NCSP37512X NCSPRINTER RX M US
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00643169282049BALLOON NCSP37506X NCSPRINTER RX M US
00643169282032BALLOON NCSP3527X NCSPRINTER RX M US
00643169282025BALLOON NCSP3521X NCSPRINTER RX M US
00643169282018BALLOON NCSP3515X NCSPRINTER RX M US
00643169282001BALLOON NCSP3512X NCSPRINTER RX M US
00643169281998BALLOON NCSP3509X NCSPRINTER RX M US
00643169281981BALLOON NCSP3506X NCSPRINTER RX M US
00643169281974BALLOON NCSP32521X NCSPRINTER RX M US
00643169281967BALLOON NCSP32515X NCSPRINTER RX M US
00643169281950BALLOON NCSP32512X NCSPRINTER RX M US
00643169281943BALLOON NCSP32509X NCSPRINTER RX M US
00643169281936BALLOON NCSP32506X NCSPRINTER RX M US
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