CAPSUREFIX® NOVUS

GUDID 00885074200682

LEAD 407652 CAPSUREFIX NOVUS PACE US

MEDTRONIC, INC.

Endocardial pacing lead
Primary Device ID00885074200682
NIH Device Record Key1f7428b8-0b0c-49ad-8c2e-86e9512fa1c1
Commercial Distribution Discontinuation2018-06-21
Commercial Distribution StatusNot in Commercial Distribution
Brand NameCAPSUREFIX® NOVUS
Version Model Number407652
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 Producttrue
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

Device Dimensions

Length52 Centimeter
Length52 Centimeter
Length52 Centimeter
Length52 Centimeter
Length52 Centimeter
Length52 Centimeter
Length52 Centimeter
Length52 Centimeter
Length52 Centimeter
Length52 Centimeter
Length52 Centimeter
Length52 Centimeter
Length52 Centimeter
Length52 Centimeter
Length52 Centimeter
Length52 Centimeter
Length52 Centimeter
Length52 Centimeter
Length52 Centimeter
Length52 Centimeter
Length52 Centimeter
Length52 Centimeter
Length52 Centimeter
Length52 Centimeter
Length52 Centimeter
Length52 Centimeter
Length52 Centimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100885074200682 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DTBpermanent pacemaker Electrode

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-07-06
Device Publish Date2014-09-23

On-Brand Devices [CAPSUREFIX® NOVUS]

00613994329400LEAD 407685 CAPSFIX NOVUS ACTBI PLY STRT
00613994329394LEAD 407665 CAPSFIX NOVUS ACTBI PLY STRT
00613994329387LEAD 407635 CAPSFIX NOVUS ACTBI PLY STRT
00643169550872LEAD 407625 CAPSUREFIX NOVUS PACE US
00643169550865LEAD 4076110 CAPSUREFIX NOVUS PACE US
00643169550858LEAD 407685 CAPSUREFIX NOVUS PACE US
00643169550841LEAD 407665 CAPSUREFIX NOVUS PACE US
00643169550834LEAD 407635 CAPSUREFIX NOVUS PACE US
00643169550827LEAD 407658 CAPSUREFIX NOVUS PACE US
00643169550810LEAD 407652 CAPSUREFIX NOVUS PACE US
00643169550803LEAD 407645 CAPSUREFIX NOVUS PACE US
00681490730099LEAD 5076-85 STERIOD SCR-IN SIL BIP
00681490730068LEAD 5076-65 BI SIL SCR-IN STER US EN
00681490729963LEAD 5076-35 CAPSURE FIX NOVUS US
00681490124867LEAD 5076-58 CAPSUREFIX NOVUS US EN
00681490124812LEAD 5076-52 CAPSUREFIX NOVUS US EN
00681490124799LEAD 5076-45 CAPSUREFIX NOVUS US EN
00721902309656LEAD 5076110 SM BI SIL SCR-IN STER
00885074200699LEAD 407658 CAPSUREFIX NOVUS PACE US
00885074200682LEAD 407652 CAPSUREFIX NOVUS PACE US
00885074200675LEAD 407645 CAPSUREFIX NOVUS PACE US

Trademark Results [CAPSUREFIX]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CAPSUREFIX
CAPSUREFIX
74330839 1841274 Live/Registered
Medtronic, Inc.
1992-11-13

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