Solia 395134

GUDID 04035479132606

BIOTRONIK SE & Co. KG

Endocardial pacing lead Endocardial pacing lead Endocardial pacing lead Endocardial pacing lead Endocardial pacing lead Endocardial pacing lead Endocardial pacing lead Endocardial pacing lead Endocardial pacing lead Endocardial pacing lead Endocardial/interventricular septal pacing lead Endocardial/interventricular septal pacing lead Endocardial/interventricular septal pacing lead Endocardial/interventricular septal pacing lead Endocardial/interventricular septal pacing lead Endocardial/interventricular septal pacing lead Endocardial/interventricular septal pacing lead Endocardial/interventricular septal pacing lead Endocardial/interventricular septal pacing lead Endocardial/interventricular septal pacing lead Endocardial/interventricular septal pacing lead Endocardial/interventricular septal pacing lead Endocardial/interventricular septal pacing lead Endocardial/interventricular septal pacing lead Endocardial/interventricular septal pacing lead Endocardial/interventricular septal pacing lead Endocardial/interventricular septal pacing lead
Primary Device ID04035479132606
NIH Device Record Key4bc749e0-7538-4254-ad45-77d15fc6c0c4
Commercial Distribution StatusIn Commercial Distribution
Brand NameSolia
Version Model NumberJT 53
Catalog Number395134
Company DUNS315620229
Company NameBIOTRONIK SE & Co. KG
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Producttrue
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(888)345-0374
Emailjon.brumbaugh@biotronik.com
Phone+1(888)345-0374
Emailjon.brumbaugh@biotronik.com
Phone+1(888)345-0374
Emailjon.brumbaugh@biotronik.com
Phone+1(888)345-0374
Emailjon.brumbaugh@biotronik.com
Phone+1(888)345-0374
Emailjon.brumbaugh@biotronik.com
Phone+1(888)345-0374
Emailjon.brumbaugh@biotronik.com
Phone+1(888)345-0374
Emailjon.brumbaugh@biotronik.com
Phone+1(888)345-0374
Emailjon.brumbaugh@biotronik.com
Phone+1(888)345-0374
Emailjon.brumbaugh@biotronik.com
Phone+1(888)345-0374
Emailjon.brumbaugh@biotronik.com
Phone+1(888)345-0374
Emailjon.brumbaugh@biotronik.com
Phone+1(888)345-0374
Emailjon.brumbaugh@biotronik.com
Phone+1(888)345-0374
Emailjon.brumbaugh@biotronik.com
Phone+1(888)345-0374
Emailjon.brumbaugh@biotronik.com
Phone+1(888)345-0374
Emailjon.brumbaugh@biotronik.com
Phone+1(888)345-0374
Emailjon.brumbaugh@biotronik.com
Phone+1(888)345-0374
Emailjon.brumbaugh@biotronik.com
Phone+1(888)345-0374
Emailjon.brumbaugh@biotronik.com
Phone+1(888)345-0374
Emailjon.brumbaugh@biotronik.com
Phone+1(888)345-0374
Emailjon.brumbaugh@biotronik.com
Phone+1(888)345-0374
Emailjon.brumbaugh@biotronik.com
Phone+1(888)345-0374
Emailjon.brumbaugh@biotronik.com
Phone+1(888)345-0374
Emailjon.brumbaugh@biotronik.com
Phone+1(888)345-0374
Emailjon.brumbaugh@biotronik.com
Phone+1(888)345-0374
Emailjon.brumbaugh@biotronik.com
Phone+1(888)345-0374
Emailjon.brumbaugh@biotronik.com
Phone+1(888)345-0374
Emailjon.brumbaugh@biotronik.com
Phone+1(888)345-0374
Emailjon.brumbaugh@biotronik.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store at temperatures up to 77¿F; excursions permitted from 41¿F to 131¿F
Storage Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store at temperatures up to 77¿F; excursions permitted from 41¿F to 131¿F
Storage Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store at temperatures up to 77¿F; excursions permitted from 41¿F to 131¿F
Storage Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store at temperatures up to 77¿F; excursions permitted from 41¿F to 131¿F
Storage Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store at temperatures up to 77¿F; excursions permitted from 41¿F to 131¿F
Storage Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store at temperatures up to 77¿F; excursions permitted from 41¿F to 131¿F
Storage Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store at temperatures up to 77¿F; excursions permitted from 41¿F to 131¿F
Storage Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store at temperatures up to 77¿F; excursions permitted from 41¿F to 131¿F
Storage Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store at temperatures up to 77¿F; excursions permitted from 41¿F to 131¿F
Storage Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store at temperatures up to 77¿F; excursions permitted from 41¿F to 131¿F
Storage Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store at temperatures up to 77¿F; excursions permitted from 41¿F to 131¿F
Storage Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store at temperatures up to 77¿F; excursions permitted from 41¿F to 131¿F
Storage Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store at temperatures up to 77¿F; excursions permitted from 41¿F to 131¿F
Storage Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store at temperatures up to 77¿F; excursions permitted from 41¿F to 131¿F
Storage Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store at temperatures up to 77¿F; excursions permitted from 41¿F to 131¿F
Storage Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store at temperatures up to 77¿F; excursions permitted from 41¿F to 131¿F
Storage Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store at temperatures up to 77¿F; excursions permitted from 41¿F to 131¿F
Storage Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store at temperatures up to 77¿F; excursions permitted from 41¿F to 131¿F
Storage Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store at temperatures up to 77¿F; excursions permitted from 41¿F to 131¿F
Storage Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store at temperatures up to 77¿F; excursions permitted from 41¿F to 131¿F
Storage Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store at temperatures up to 77¿F; excursions permitted from 41¿F to 131¿F
Storage Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store at temperatures up to 77¿F; excursions permitted from 41¿F to 131¿F
Storage Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store at temperatures up to 77¿F; excursions permitted from 41¿F to 131¿F
Storage Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store at temperatures up to 77¿F; excursions permitted from 41¿F to 131¿F
Storage Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store at temperatures up to 77¿F; excursions permitted from 41¿F to 131¿F
Storage Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store at temperatures up to 77¿F; excursions permitted from 41¿F to 131¿F
Storage Environment TemperatureBetween 0 and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS104035479132606 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NVNDrug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2021-02-05
Device Publish Date2018-08-30

On-Brand Devices [Solia]

04035479136567JT 45
04035479132606JT 53
04035479118297T 60
04035479118280T 53
04035479118273S 60
04035479118266S 53
04035479118259S 45

Trademark Results [Solia]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SOLIA
SOLIA
88532744 not registered Live/Pending
Solia Societe Anonyme France
2019-07-24
SOLIA
SOLIA
86841461 5012379 Live/Registered
Vidya Industries, LLC
2015-12-07
SOLIA
SOLIA
86498555 4807364 Live/Registered
Solia Spa Inc.
2015-01-08
SOLIA
SOLIA
85874935 4418505 Live/Registered
HAUTEHOUSE, LLC
2013-03-13
SOLIA
SOLIA
85386027 4114621 Live/Registered
Solia Digital Media, LLC
2011-08-01
SOLIA
SOLIA
85087823 4058411 Live/Registered
BIOTRONIK SE & Co. KG
2010-07-19
SOLIA
SOLIA
79149177 4753767 Live/Registered
VEOLIA WATER SOLUTIONS & TECHNOLOGIES SUPPORT
2014-02-18
SOLIA
SOLIA
79044787 3547041 Dead/Cancelled
SOLIA
2007-07-18
SOLIA
SOLIA
78919041 3239443 Dead/Cancelled
American Beauty Supply, Inc.
2006-06-28
SOLIA
SOLIA
78574248 3156436 Dead/Cancelled
Monarch Computer Systems, Inc.
2005-02-24
SOLIA
SOLIA
78536351 not registered Dead/Abandoned
Monarch Computer Systems, Inc.
2004-12-21
SOLIA
SOLIA
78454998 not registered Dead/Abandoned
Hong Shen
2004-07-22

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