Neuro PR app 2400.U 493241

GUDID 04035479188733

BIOTRONIK SE & Co. KG

Implantable electrical stimulation device management software
Primary Device ID04035479188733
NIH Device Record Keyadbb67f1-d193-408e-915f-02da1245e2f1
Commercial Distribution StatusIn Commercial Distribution
Brand NameNeuro PR app 2400.U
Version Model Number493241
Catalog Number493241
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 Usefalse
Lot Batchfalse
Serial Numberfalse
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(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 Identifiers

Device Issuing AgencyDevice ID
GS104035479188733 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LGWStimulator, spinal-cord, totally implanted for pain relief

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-04-04
Device Publish Date2025-03-27

Devices Manufactured by BIOTRONIK SE & Co. KG

04035479185817 - Neuro CP app 2300.U2025-04-04
04035479188733 - Neuro PR app 2400.U2025-04-04
04035479188733 - Neuro PR app 2400.U2025-04-04
04035479184445 - PatientApp 2.82025-02-20
04035479187927 - SW HMSC 3.622025-01-28
04035479188399 - NEO 2401.U/12024-12-26
04035479001575 - M-502024-10-24
04035479176143 - Home Monitoring Service Center2024-09-30
04035479184636 - Home Monitoring Service Center2024-09-23

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