Sprinter Legend™

GUDID 00643169854956

BLN SPL12512WL SPR LEGEND 1.25X12 OTW US

MEDTRONIC, INC.

Coronary angioplasty balloon catheter, basic
Primary Device ID00643169854956
NIH Device Record Keye0276543-3e89-4009-ae25-01acec3ab9f3
Commercial Distribution StatusIn Commercial Distribution
Brand NameSprinter Legend™
Version Model NumberSPL12512WL
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

Length12 Millimeter
Length12 Millimeter
Length12 Millimeter
Length12 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169854956 [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 Date2018-01-14

On-Brand Devices [Sprinter Legend™]

00643169854970BLN SPL12520WL SPR LEGEND 1.25X20 OTW US
00643169854963BLN SPL12515WL SPR LEGEND 1.25X15 OTW US
00643169854956BLN SPL12512WL SPR LEGEND 1.25X12 OTW US
00643169854949BLN SPL12510WL SPR LEGEND 1.25X10 OTW US
00643169854932BLN SPL12506WL SPR LEGEND 1.25X6 OTW US

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