GUDID 08714729935148

Clinician Programmer (Refurbished)

BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

Deep brain electrical stimulation system
Primary Device ID08714729935148
NIH Device Record Key9e0eb599-3677-4bf0-a8e8-ae683c505111
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberDB-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
GS108714729935148 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHLSTIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-10-29
Device Publish Date2017-12-12

Devices Manufactured by BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

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08714729966357 - Vercise™ Cartesia™ HX2024-12-23 Directional Lead Kit, 16 Contact, 30cm
08714729966364 - Vercise™ Cartesia™ HX2024-12-23 Directional Lead Kit, 16 Contact, 45cm
08714729966371 - NA2024-12-23 Lead Extension Kit, 2x8 Contact, 55cm
08714729966388 - NA2024-12-23 Lead Extension Kit, 2x8 Contact, 95cm
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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