LOCALISA®

GUDID 20643169006878

ELECTRODE 9670590 5BX LOCALISA

MEDTRONIC, INC.

Cardiac mapping system reference patch
Primary Device ID20643169006878
NIH Device Record Keyf4d0b375-3710-43fa-bdca-d94405d713fb
Commercial Distribution StatusIn Commercial Distribution
Brand NameLOCALISA®
Version Model Number9670590
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

Operating and Storage Conditions

Storage Environment TemperatureBetween -10 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169006874 [Primary]
GS120643169006878 [Package]
Contains: 00643169006874
Package: PK [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DQKCOMPUTER, DIAGNOSTIC, PROGRAMMABLE

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-06-30

Devices Manufactured by MEDTRONIC, INC.

20763000980096 - NA2025-08-25 IMPEDANCE PATCH AFR-00015
20763000980119 - NA2025-08-25 MAGNETIC PATCH AFR-00021
00199150039371 - NA2025-08-22 CUSTOM PACK BB11U72R1 P/T
00199150040872 - NA2025-08-22 CUSTOM PACK BB4K95R22 HLO PERFNPLEG
00199150041145 - NA2025-08-22 CUSTOM PACK BB12Q87R1 HLN VAMC NASH
00199150041978 - NA2025-08-22 CUSTOM PACK BB10F40R2 ACCESORY
00199150041299 - NA2025-08-19 CUSTOM PACK BB8E60R12 EVL PED E
20199150041118 - NA2025-08-18 CUSTOM PACK BB12E30R1 10PK ACC BRIDGE

Trademark Results [LOCALISA]

Mark Image

Registration | Serial
Company
Trademark
Application Date
LOCALISA
LOCALISA
75809978 2652262 Dead/Cancelled
Medtronic, Inc.
1999-09-28

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.