GUDID 08714729121411

OR Cable and Extension

BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

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Primary Device ID08714729121411
NIH Device Record Keydae50207-ee4d-4ba3-bd85-ca449ce0542d
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberSC-4100A
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108714729121411 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MHYStimulator, electrical, implanted, for parkinsonian tremor

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-11-24
Device Publish Date2015-11-09

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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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