DBS™

GUDID 00613994981356

LEAD 3389S-28 DBS ACTIVA STMLC LCAP EMAN

MEDTRONIC, INC.

Deep brain electrical stimulation system
Primary Device ID00613994981356
NIH Device Record Key2be41008-f285-40fb-a654-31b7940b69e0
Commercial Distribution StatusIn Commercial Distribution
Brand NameDBS™
Version Model Number3389S-28
Company DUNS796986144
Company NameMEDTRONIC, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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
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 Dimensions

Length28 Centimeter
Length28 Centimeter
Length28 Centimeter
Length28 Centimeter
Length28 Centimeter
Length28 Centimeter
Length28 Centimeter
Length28 Centimeter
Length28 Centimeter
Length28 Centimeter
Length28 Centimeter
Length28 Centimeter
Length28 Centimeter
Length28 Centimeter
Length28 Centimeter
Length28 Centimeter
Length28 Centimeter
Length28 Centimeter
Length28 Centimeter
Length28 Centimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100613994981356 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MRUimplanted subcortical electrical Stimulator (motor disorders)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-11-22
Device Publish Date2014-09-23

On-Brand Devices [DBS™]

00613994844668ACCY 3755 TUNNELING TOOL DBS US
00613994749161EXTENSION 748351 DBS NO TUNNEL TOOL US
00613994749123EXTENSION 3708695 DBS NO TUNNEL TOOL US
00613994749116EXTENSION 3708660 DBS NO TUNNEL TOOL US
00613994749109EXTENSION 3708640 DBS NO TUNNEL TOOL US
00613994981363LEAD 3389S-40 DBS ACTIVA STMLC LCAP EMAN
00613994981356LEAD 3389S-28 DBS ACTIVA STMLC LCAP EMAN
00643169752290LEAD 3387S-40 EMAN SCNR CBL RMV MR CDTNL
00643169752283LEAD 3389S-28 EMAN SCNR CBL RMV MR CDTNL
00643169752276LEAD 3389S-40 EMAN SCNR CBL RMV MR CDTNL
00763000306687ACCY KIT 3755 DBS TUNNELING TOOL 40CM
00763000274412LEAD KIT 3391S-40 DBS STMLC RECLAIM EMAN
00763000274405LEAD KIT 3389S-40 DBS STMLOC ACTIVA EMAN
00763000274399LEAD KIT 3389S-28 DBS STMLOC ACTIVA EMAN
00763000274320LEAD KIT 3387S-40 DBS STMLOC ACTIVA EMAN

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