GUDID 08714729897804

Installer for BN3.1

BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

Implantable electrical stimulation device management software
Primary Device ID08714729897804
NIH Device Record Key6765da28-f8ff-422d-a232-0596c5680a8a
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberSC-7102
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 Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS108714729897804 [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 StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2024-08-21
Device Publish Date2015-09-04

Devices Manufactured by BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

08714729950684 - Entrada ™2025-08-25 Needle 11cm (4.5in)
08714729950691 - Entrada ™2025-08-25 Needle 15cm (6.0 in)
08714729950707 - Entrada ™2025-08-25 Spare Sheath 11cm (4.5 in)
08714729950714 - Entrada ™2025-08-25 Spare Sheath 15cm (6.0 in)
08714729952053 - Freelink™2025-08-25 Remote Control
08714729953449 - Freelink™2025-08-25 Remote Control Kit
08714729953487 - Bionic Navigator™ 3D2025-08-25 BN 3D 2.0 Installer
08714729820758 - Vercise™2025-08-12 Implantable Pulse Generator Kit

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