NC Stormer™ OTW

GUDID 00643169849969

BALLOON NCS27516W NC STORMER OTW

MEDTRONIC, INC.

Coronary angioplasty balloon catheter, basic
Primary Device ID00643169849969
NIH Device Record Keyfa666cb0-bd13-4dff-bf4f-c45f74955dd8
Commercial Distribution StatusIn Commercial Distribution
Brand NameNC Stormer™ OTW
Version Model NumberNCS27516W
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 Diameter2.75 Millimeter
Outer Diameter2.75 Millimeter
Outer Diameter2.75 Millimeter
Outer Diameter2.75 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169849969 [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 Date2017-11-13

On-Brand Devices [NC Stormer™ OTW]

00643169850309BALLOON NCS4021W NC STORMER OTW
00643169850293BALLOON NCS4018W NC STORMER OTW
00643169850286BALLOON NCS4016W NC STORMER OTW
00643169850279BALLOON NCS4014W NC STORMER OTW
00643169850262BALLOON NCS4011W NC STORMER OTW
00643169850255BALLOON NCS4006W NC STORMER OTW
00643169850248BALLOON NCS37521W NC STORMER OTW
00643169850231BALLOON NCS37518W NC STORMER OTW
00643169850224BALLOON NCS37516W NC STORMER OTW
00643169850217BALLOON NCS37514W NC STORMER OTW
00643169850200BALLOON NCS37511W NC STORMER OTW
00643169850194BALLOON NCS37506W NC STORMER OTW
00643169850187BALLOON NCS3521W NC STORMER OTW
00643169850170BALLOON NCS3518W NC STORMER OTW
00643169850163BALLOON NCS3516W NC STORMER OTW
00643169850156BALLOON NCS3514W NC STORMER OTW
00643169850149BALLOON NCS3511W NC STORMER OTW
00643169850132BALLOON NCS3506W NC STORMER OTW
00643169850125BALLOON NCS32521W NC STORMER OTW
00643169850118BALLOON NCS32518W NC STORMER OTW
00643169850101BALLOON NCS32516W NC STORMER OTW
00643169850095BALLOON NCS32514W NC STORMER OTW
00643169850088BALLOON NCS32511W NC STORMER OTW
00643169850071BALLOON NCS32506W NC STORMER OTW
00643169850064BALLOON NCS3031W NC STORMER OTW
00643169850057BALLOON NCS3026W NC STORMER OTW
00643169850040BALLOON NCS3021W NC STORMER OTW
00643169850033BALLOON NCS3018W NC STORMER OTW
00643169850026BALLOON NCS3016W NC STORMER OTW
00643169850019BALLOON NCS3014W NC STORMER OTW
00643169850002BALLOON NCS3011W NC STORMER OTW
00643169849990BALLOON NCS3006W NC STORMER OTW
00643169849983BALLOON NCS27521W NC STORMER OTW
00643169849976BALLOON NCS27518W NC STORMER OTW
00643169849969BALLOON NCS27516W NC STORMER OTW
00643169849952BALLOON NCS27514W NC STORMER OTW
00643169849945BALLOON NCS27511W NC STORMER OTW
00643169849938BALLOON NCS27506W NC STORMER OTW
00643169849921BALLOON NCS2531W NC STORMER OTW
00643169849914BALLOON NCS2526W NC STORMER OTW
00643169849907BALLOON NCS2521W NC STORMER OTW
00643169849891BALLOON NCS2518W NC STORMER OTW
00643169849884BALLOON NCS2516W NC STORMER OTW
00643169849877BALLOON NCS2514W NC STORMER OTW
00643169849860BALLOON NCS2511W NC STORMER OTW
00643169849853BALLOON NCS2506W NC STORMER OTW
00643169849846BALLOON NCS22521W NC STORMER OTW
00643169849839BALLOON NCS22516W NC STORMER OTW
00643169849822BALLOON NCS22511W NC STORMER OTW
00643169849815BALLOON NCS22506W NC STORMER OTW

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