EFH-16 115489

GUDID 04035479002916

BIOTRONIK SE & Co. KG

Pacing/defibrillation lead suture sleeve Pacing/defibrillation lead suture sleeve Pacing/defibrillation lead suture sleeve Pacing/defibrillation lead suture sleeve Pacing/defibrillation lead suture sleeve Pacing/defibrillation lead suture sleeve Pacing/defibrillation lead suture sleeve Pacing/defibrillation lead suture sleeve Pacing/defibrillation lead suture sleeve Pacing/defibrillation lead suture sleeve Pacing/defibrillation lead suture sleeve Pacing/defibrillation lead suture sleeve Pacing/defibrillation lead suture sleeve Pacing/defibrillation lead suture sleeve Pacing/defibrillation lead suture sleeve Pacing/defibrillation lead suture sleeve Pacing/defibrillation lead suture sleeve
Primary Device ID04035479002916
NIH Device Record Keya8c9ebc1-48a6-4484-ba36-14629f5c85df
Commercial Distribution StatusIn Commercial Distribution
Brand NameEFH-16
Version Model Number115489
Catalog Number115489
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 Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains 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

Operating and Storage Conditions

Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 131 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS104035479002916 [Package]
Contains: 04035479144821
Package: case [10 Units]
In Commercial Distribution
GS104035479144821 [Primary]

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 Date2019-10-28
Device Publish Date2014-08-14

Devices Manufactured by BIOTRONIK SE & Co. KG

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04035479184285 - NEO2023-12-25
04035479184292 - PSW2023-12-25
04035479185510 - Renamic Neo NEOexpress2023-12-25
04035479183264 - Home Monitoring Service Center2023-10-23
04035479100650 - S 60-C2023-10-09
04035479011864 - S 75-A2023-10-06

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