GUDID 08714729989271

Charger Belt, Small, Black

BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

Deep brain electrical stimulation system
Primary Device ID08714729989271
NIH Device Record Key382537df-11e0-49bb-829d-e12379a43bee
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberDB-6358-0BK
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
GS108714729989271 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MHYStimulator, electrical, implanted, for parkinsonian tremor
NHLStimulator, electrical, implanted, for parkinsonian symptoms

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-02-05
Device Publish Date2021-01-28

Devices Manufactured by BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

08714729897804 - NA2024-08-21 Installer for BN3.1
08714729897811 - NA2024-08-21 Clinician Programmer
08714729897835 - Precision Novi™2024-08-21 Implantable Pulse Generator Kit
08714729897873 - NA2024-08-21 Clinican Programmer (Refurbished)
08714729904816 - Avista™ MRI2024-08-21 56cm 8 Contact Lead Kit
08714729904823 - Avista™ MRI2024-08-21 74cm 8 Contact Lead Kit
08714729905387 - Freelink™2024-08-21 Remote Control
08714729905486 - Freelink™2024-08-21 Remote Control Kit

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