M365DB3216950

GUDID 08714729966401

16 Contact Lead Extension Kit, 95 cm

BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

Deep brain electrical stimulation system
Primary Device ID08714729966401
NIH Device Record Keyc802693f-f67d-4b3e-bb54-e310d9801f37
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberDB-3216-95
Catalog NumberM365DB3216950
Company DUNS824951958
Company NameBOSTON SCIENTIFIC NEUROMODULATION CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Length95 Centimeter
Length95 Centimeter
Length95 Centimeter
Length95 Centimeter
Length95 Centimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS108714729966401 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-12-23
Device Publish Date2024-12-15

Devices Manufactured by BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

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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 - NA2024-12-2316 Contact Lead Extension Kit, 95 cm
08714729966401 - NA2024-12-23 16 Contact Lead Extension Kit, 95 cm

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