SureTek™

GUDID 08714729820819

Burr Hole Cover Spares Kit

BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

Deep brain electrical stimulation system
Primary Device ID08714729820819
NIH Device Record Key285a81b4-045d-48fb-b453-1bbfbd7f21f2
Commercial Distribution StatusIn Commercial Distribution
Brand NameSureTek™
Version Model NumberDB-4605-C
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 Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108714729820819 [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 StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2021-10-29
Device Publish Date2017-12-15

On-Brand Devices [SureTek™]

08714729820819Burr Hole Cover Spares Kit
08714729820802Burr Hole Cover Kit

Trademark Results [SureTek]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SURETEK
SURETEK
85460621 4795452 Live/Registered
Boston Scientific Neuromodulation Corporation
2011-10-31

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