Bionic Navigator™ 3D

GUDID 00191506007546

4.1 Installer

BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

Implantable electrical stimulation device management software
Primary Device ID00191506007546
NIH Device Record Key18a898a9-db1b-4197-91b7-ca74d5b1948d
Commercial Distribution StatusIn Commercial Distribution
Brand NameBionic Navigator™ 3D
Version Model NumberSC-7101-410
Company DUNS824951958
Company NameBOSTON SCIENTIFIC NEUROMODULATION CORPORATION
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 Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100191506007546 [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 Date2021-08-23
Device Publish Date2021-08-15

On-Brand Devices [Bionic Navigator™ 3D]

087147299903762.20 Installer
087147299913662.20 Installer
087147299913732.10 Installer
087147299952034.0 Installer
001915060075464.1 Installer

Trademark Results [Bionic Navigator]

Mark Image

Registration | Serial
Company
Trademark
Application Date
BIONIC NAVIGATOR
BIONIC NAVIGATOR
78232729 3036464 Live/Registered
BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
2003-04-01

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