GUDID 08714729820949

Base Station

BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

Deep brain electrical stimulation system
Primary Device ID08714729820949
NIH Device Record Key60d27951-5323-4081-96bd-3bbca0e03df2
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberNM-5305
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
GS108714729820949 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MHYStimulator, electrical, implanted, for parkinsonian tremor

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

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

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08714729121473 - Precision™2026-01-19 Suture Sleeve 2.3cm Tapered
08714729121480 - Precision™2026-01-19 Suture Sleeve 4cm Segmented
08714729767572 - Precision ™2026-01-19 Passing Elevator
08714729767626 - Precision™2026-01-19 Suture Sleeve 2.3cm Split
08714729767756 - Precision™2026-01-19 Suture Sleeve 1cm Split
08714729767763 - Precision™2026-01-19 Suture Sleeve 4cm Split
08714729905318 - Clik™ X2025-12-17 Anchor

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