GUDID 08714729935056

Clinician Programmer

BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

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Primary Device ID08714729935056
NIH Device Record Key74524e29-1eaa-4f48-8a2f-af5cd4e6f6b8
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberNM-7161
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 Numbertrue
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
GS108714729935056 [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 Date2021-11-24
Device Publish Date2017-04-14

Devices Manufactured by BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

08714729121688 - Precision ™2024-03-25 Adhesive Kit
08714729121435 - Precision™2024-03-19 Hex Wrench
08714729121442 - NA2024-03-19 10cm (4 Inch) Insertion Needle
08714729121459 - NA2024-03-19 13cm (5 Inch) Insertion Needle
08714729121497 - NA2024-03-19 Stylet Kit with Stylet Cap 30cm
08714729121503 - NA2024-03-19 Stylet Kit with Stylet Cap 50cm
08714729121510 - NA2024-03-19 Stylet Kit with Stylet Cap 70cm
08714729121558 - NA2024-03-19 Enhanced Steering Kit with Stylet Cap 30cm

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