NC STORMER® OTW

GUDID 00885074202211

2.5 X 6MM NC STORMER OTW BALLOON CATHETE

MEDTRONIC, INC.

Coronary angioplasty balloon catheter, basic
Primary Device ID00885074202211
NIH Device Record Key3b803b26-ae0b-4d64-bf22-a64b35301661
Commercial Distribution StatusIn Commercial Distribution
Brand NameNC STORMER® OTW
Version Model NumberNCS2506W
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

Device Dimensions

Outer Diameter2.5 Millimeter
Outer Diameter2.5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100885074202211 [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 Date2016-04-18

On-Brand Devices [NC STORMER® OTW]

008850742028914.0 X 21MM NC STORMER OTW BALLOON CATHET
008850742028774.0 X 18MM NC STORMER OTW BALLOON CATHET
008850742028534.0 X 16MM NC STORMER OTW BALLOON CATHET
008850742028464.0 X 14MM NC STORMER OTW BALLOON CATHET
008850742028394.0 X 11MM NC STORMER OTW BALLOON CATHET
008850742028224.0 X 6MM NC STORMER OTW BALLOON CATHETE
008850742027923.75 X 21MM NC STORMER OTW BALLOON CATHE
008850742027853.75 X 18MM NC STORMER OTW BALLOON CATHE
008850742027783.75 X 16MM NC STORMER OTW BALLOON CATHE
008850742027613.75 X 14MM NC STORMER OTW BALLOON CATHE
008850742027543.75 X 11MM NC STORMER OTW BALLOON CATHE
008850742027303.75 X 6MM NC STORMER OTW BALLOON CATHET
008850742026933.5 X 21MM NC STORMER OTW BALLOON CATHET
008850742026863.5 X18MM NC STORMER OTW BALLOON CATHETE
008850742026793.5 X 16MM NC STORMER OTW BALLOON CATHET
008850742026623.5 X14MM NC STORMER OTW BALLOON CATHETE
008850742026553.5 X 11MM NC STORMER OTW BALLOON CATHET
008850742026483.5 X 6MM NC STORMER OTW BALLOON CATHETE
008850742026173.25 X 21MM NC STORMER OTW BALLOON CATHE
008850742026003.25 X18MM NC STORMER OTW BALLOON CATHET
008850742025943.25 X 16MM NC STORMER OTW BALLOON CATHE
008850742025873.25 X14MM NC STORMER OTW BALLOON CATHET
008850742025703.25 X 11MM NC STORMER OTW BALLOON CATHE
008850742025633.25 X 6MM NC STORMER OTW BALLOON CATHET
008850742024403.0 X 31MM NC STORMER OTW BALLOON CATHET
008850742024333.0 X 26MM NC STORMER OTW BALLOON CATHET
008850742024263.0 X 21MM NC STORMER OTW BALLOON CATHET
008850742024193.0 X18MM NC STORMER OTW BALLOON CATHETE
008850742024023.0 X 16MM NC STORMER OTW BALLOON CATHET
008850742023963.0 X14MM NC STORMER OTW BALLOON CATHETE
008850742023893.0 X 11MM NC STORMER OTW BALLOON CATHET
008850742023723.0 X 6MM NC STORMER OTW BALLOON CATHETE
008850742023412.75 X 21MM NC STORMER OTW BALLOON CATHE
008850742023342.75 X18MM NC STORMER OTW BALLOON CATHET
008850742023272.75 X 16MM NC STORMER OTW BALLOON CATHE
008850742023102.75 X14MM NC STORMER OTW BALLOON CATHET
008850742023032.75 X 11MM NC STORMER OTW BALLOON CATHE
008850742022972.75 X 6MM NC STORMER OTW BALLOON CATHET
008850742022802.5 X 31MM NC STORMER OTW BALLOON CATHET
008850742022732.5 X 26MM NC STORMER OTW BALLOON CATHET
008850742022662.5 X 21MM NC STORMER OTW BALLOON CATHET
008850742022592.5 X18MM NC STORMER OTW BALLOON CATHETE
008850742022422.5 X 16MM NC STORMER OTW BALLOON CATHET
008850742022352.5 X 14MM NC STORMER OTW BALLOON CATHET
008850742022282.5 X 11MM NC STORMER OTW BALLOON CATHET
008850742022112.5 X 6MM NC STORMER OTW BALLOON CATHETE
008850742021812.25 X 21MM NC STORMER OTW BALLOON CATHE
008850742021672.25 X 16MM NC STORMER OTW BALLOON CATHE
008850742021432.25 X 11MM NC STORMER OTW BALLOON CATHE
008850742021362.25 X 6MM NC STORMER OTW BALLOON CATHET

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.