GUDID 08714729996729

Pairing Magnet

BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

Deep brain electrical stimulation system Deep brain electrical stimulation system Deep brain electrical stimulation system Deep brain electrical stimulation system Deep brain electrical stimulation system Deep brain electrical stimulation system Deep brain electrical stimulation system Deep brain electrical stimulation system Deep brain electrical stimulation system Deep brain electrical stimulation system Deep brain electrical stimulation system Deep brain electrical stimulation system Deep brain electrical stimulation system Deep brain electrical stimulation system Deep brain electrical stimulation system Deep brain electrical stimulation system Deep brain electrical stimulation system Deep brain electrical stimulation system Deep brain electrical stimulation system Deep brain electrical stimulation system Deep brain electrical stimulation system Deep brain electrical stimulation system Deep brain electrical stimulation system Deep brain electrical stimulation system Deep brain electrical stimulation system
Primary Device ID08714729996729
NIH Device Record Key63ba4ac4-7fa7-4b60-907f-4f0e1e3d7418
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberDB-6386
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
GS108714729996729 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

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 Date2021-02-05
Device Publish Date2021-01-28

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.