Neuro CP app 2300.U 487878

GUDID 04035479185817

BIOTRONIK SE & Co. KG

Implantable electrical stimulation device management software
Primary Device ID04035479185817
NIH Device Record Keycbe0edfb-3f97-4190-a09b-1e74eabfa5f7
Commercial Distribution StatusIn Commercial Distribution
Brand NameNeuro CP app 2300.U
Version Model Number487878
Catalog Number487878
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
GS104035479185817 [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
04035479185817 - Neuro CP app 2300.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

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.