Syncra™ CRT-P

GUDID 00613994753304

CRT-P C2TR01 SYNCRA IS-1 US MR

MEDTRONIC, INC.

Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker
Primary Device ID00613994753304
NIH Device Record Key65c38291-9862-4f17-90db-f2fcf1c6eaee
Commercial Distribution StatusIn Commercial Distribution
Brand NameSyncra™ CRT-P
Version Model NumberC2TR01
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 Batchfalse
Serial Numbertrue
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
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Operating and Storage Conditions

Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100613994753304 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKEPulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-06-28
Device Publish Date2014-09-23

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Trademark Results [Syncra]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SYNCRA
SYNCRA
88391995 not registered Live/Pending
Sunrise Medical (US) LLC
2019-04-18
SYNCRA
SYNCRA
88057549 not registered Dead/Abandoned
Carrier Corporation
2018-07-30
SYNCRA
SYNCRA
86214746 4740430 Live/Registered
Ecolab USA Inc.
2014-03-07
SYNCRA
SYNCRA
79064733 3778219 Dead/Cancelled
Danisco US Inc.
2008-12-30
SYNCRA
SYNCRA
77869384 4354262 Live/Registered
Medtronic, Inc.
2009-11-10
SYNCRA
SYNCRA
76322217 2642520 Dead/Cancelled
Syncra Systems, Inc.
2001-10-05
SYNCRA
SYNCRA
76321847 2665986 Dead/Cancelled
Syncra Systems, Inc.
2001-10-05
SYNCRA
SYNCRA
75444211 not registered Dead/Abandoned
CollabTech, Inc.
1998-03-04

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