GUDID 08714729989301

Charger Belt Loops Replacement, Black

BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

Deep brain electrical stimulation system
Primary Device ID08714729989301
NIH Device Record Key872bc7ab-b2cb-437f-b180-672fbe8014cb
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberDB-6358-9BK
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
GS108714729989301 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHLStimulator, electrical, implanted, for parkinsonian symptoms
PJSStimulator, electrical, implanted, for essential tremor

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

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08714729966395 - NA2024-12-23 16 Contact Lead Extension Kit, 55 cm
08714729966401 - NA2024-12-23 16 Contact Lead Extension Kit, 95 cm

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