Bionic Navigator™ 3D

GUDID 08714729991366

2.20 Installer

BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

Analgesic spinal cord electrical stimulation system
Primary Device ID08714729991366
NIH Device Record Key584ebb49-9faa-487f-b37b-afdb071d7a9a
Commercial Distribution StatusIn Commercial Distribution
Brand NameBionic Navigator™ 3D
Version Model NumberSC-7101-220-W10
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 Datefalse
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
GS108714729991366 [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 Date2020-02-10
Device Publish Date2020-01-31

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.