Solox 333900

GUDID 04035479049218

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 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 ID04035479049218
NIH Device Record Key87d2515d-3ce5-4c36-9324-170f4fd04fb3
Commercial Distribution Discontinuation2020-10-16
Commercial Distribution StatusNot in Commercial Distribution
Brand NameSolox
Version Model NumberSLX 58/13-BP
Catalog Number333900
Company DUNS315620229
Company NameBIOTRONIK SE & Co. KG
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 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
Phone+1(888)345-0374
Emailjon.brumbaugh@biotronik.com
Phone+1(888)345-0374
Emailjon.brumbaugh@biotronik.com

Device Dimensions

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Operating and Storage Conditions

Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 131 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS104035479049218 [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 Date2020-10-19
Device Publish Date2014-08-21

On-Brand Devices [Solox]

04035479049232SLX 58/15-BP
04035479049218SLX 58/13-BP

Trademark Results [Solox]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SOLOX
SOLOX
97424034 not registered Live/Pending
Stillwater Designs and Audio, Inc
2022-05-23
SOLOX
SOLOX
88520407 not registered Live/Pending
NewBorn-Town Network Technology (Beijing) Co., Ltd.
2019-07-17
SOLOX
SOLOX
88520385 not registered Live/Pending
NewBorn-Town Network Technology (Beijing) Co., Ltd.
2019-07-17
SOLOX
SOLOX
88139591 not registered Live/Pending
Stillwater Designs and Audio, Inc.
2018-10-02
SOLOX
SOLOX
86750648 5009512 Live/Registered
LAM International Corporation
2015-09-08
SOLOX
SOLOX
77086308 3625126 Dead/Cancelled
Stillwater Designs and Audio, Inc.
2007-01-19
SOLOX
SOLOX
75410243 2396724 Dead/Cancelled
BIOTRONIK SE & CO. KG
1997-12-23
SOLOX
SOLOX
74290306 1759326 Dead/Cancelled
Interox International (Societe Anonyme)
1992-07-01
SOLOX
SOLOX
74269751 1881381 Dead/Cancelled
Solar Kinetics, Inc.
1992-04-24

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