GUDID 00763000253370

ACCY B31060 DBS BORE PLUG US EMAN

MEDTRONIC, INC.

Deep brain electrical stimulation system Deep brain electrical stimulation system Deep brain electrical stimulation system Deep brain electrical stimulation system Deep brain electrical stimulation system Deep brain electrical stimulation system Deep brain electrical stimulation system Deep brain electrical stimulation system Deep brain electrical stimulation system Deep brain electrical stimulation system Deep brain electrical stimulation system Deep brain electrical stimulation system Deep brain electrical stimulation system Deep brain electrical stimulation system
Primary Device ID00763000253370
NIH Device Record Keyc7122e57-e212-45e6-ac6a-eec01aee1c17
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberB31060
Company DUNS796986144
Company NameMEDTRONIC, INC.
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000253370 [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 Date2020-07-13
Device Publish Date2020-07-05

Devices Manufactured by MEDTRONIC, INC.

20763000770291 - TrailBlazer™2024-07-16 PS ASC-014-090 TRAILBLAZER ANGLED V04
20763000770307 - TrailBlazer™2024-07-16 PS ASC-014-135 TRAILBLAZER ANGLED V04
20763000770314 - TrailBlazer™2024-07-16 PS ASC-014-150 TRAILBLAZER ANGLED V04
20763000770321 - TrailBlazer™2024-07-16 PS ASC-018-090 TRAILBLAZER ANGLED V04
20763000770338 - TrailBlazer™2024-07-16 PS ASC-018-135 TRAILBLAZER ANGLED V04
20763000770345 - TrailBlazer™2024-07-16 PS ASC-018-150 TRAILBLAZER ANGLED V04
20763000770352 - TrailBlazer™2024-07-16 PS ASC-035-065 TRAILBLAZER ANGLED V04
20763000770369 - TrailBlazer™2024-07-16 PS ASC-035-090 TRAILBLAZER ANGLED V04

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.