GUDID 08714729935063

Clinician Programmer (Refurbished)

BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

Deep brain electrical stimulation system
Primary Device ID08714729935063
NIH Device Record Key040ebd2b-bc8e-4575-98b1-4b4447f5bfe9
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberNM-7161R
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
GS108714729935063 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PJSStimulator, electrical, implanted, for essential 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

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