GUDID 00191506023584

95cm, 2x8 Contact Lead Extension Kit

BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

Deep brain electrical stimulation system
Primary Device ID00191506023584
NIH Device Record Key61189f76-c1a5-40cd-9061-c0cbf007c5f0
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberDB-3128-95B
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
Length95 Centimeter
Length95 Centimeter
Length95 Centimeter
Length95 Centimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100191506023584 [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 Date2022-11-08
Device Publish Date2022-10-31

Devices Manufactured by BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

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