GUDID 08714729991212

Clinician Programmer

BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

Analgesic spinal cord electrical stimulation system
Primary Device ID08714729991212
NIH Device Record Key03537ac3-a1de-4fcf-a7fa-d0a9767292dd
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberNM-7164
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
GS108714729991212 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LGWSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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 Date2020-02-10
Device Publish Date2020-01-31

Devices Manufactured by BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

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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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