M365DB3128950

GUDID 08714729966388

Lead Extension Kit, 2x8 Contact, 95cm

BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

Deep brain electrical stimulation system
Primary Device ID08714729966388
NIH Device Record Key9a40ff94-2cf5-4fad-9867-7e4500617fa5
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberDB-3128-95
Catalog NumberM365DB3128950
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
Length95 Centimeter
Length95 Centimeter
Length95 Centimeter
Length95 Centimeter
Length95 Centimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS108714729966388 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHLStimulator, electrical, implanted, for parkinsonian symptoms

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

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