GUDID 08714729896111

O.R. Cable and Extension

BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

Deep brain electrical stimulation system
Primary Device ID08714729896111
NIH Device Record Key56d28851-6c26-482d-b9bb-6fbe7fb7fa02
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberDB-4100A
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108714729896111 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHLSTIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-10-29
Device Publish Date2017-12-15

Devices Manufactured by BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

08714729888734 - Precision™2024-09-24 M8 Adapter, 15cm
08714729888758 - Precision™2024-09-24 M8 Adapter, 55cm
08714729893271 - Precision™2024-09-24 S8 Adapter, 15cm
08714729893288 - Precision™2024-09-24 S8 Adapter, 55cm
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)

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