InterStim™ SureScan™

GUDID 00763000596835

LEAD 978A133 ISTM SSMRI 2.16MM EMAN GLBL

MEDTRONIC, INC.

Sacral plexus implantable incontinence-control electrical stimulation system electrode
Primary Device ID00763000596835
NIH Device Record Keyb10e3839-968d-4f37-b1f6-e4d935ca1fac
Commercial Distribution StatusIn Commercial Distribution
Brand NameInterStim™ SureScan™
Version Model Number978A133
Company DUNS796986144
Company NameMEDTRONIC, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
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

Device Dimensions

Length33 Centimeter
Length33 Centimeter
Length33 Centimeter
Length33 Centimeter
Length33 Centimeter
Length33 Centimeter
Length33 Centimeter
Length33 Centimeter
Length33 Centimeter
Length33 Centimeter
Length33 Centimeter
Length33 Centimeter
Length33 Centimeter
Length33 Centimeter
Length33 Centimeter
Length33 Centimeter
Length33 Centimeter
Length33 Centimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000596835 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EZWStimulator, electrical, implantable, for incontinence

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-01-30
Device Publish Date2024-01-22

On-Brand Devices [InterStim™ SureScan™]

00763000596910LEAD 978B128 ISTM SSMRI 4.32MM EMAN GLBL
00763000596798LEAD 978A128 ISTM SSMRI 2.16MM EMAN GLBL
00763000596873LEAD 978A141 ISTM SSMRI 2.16MM EMAN GLBL
00763000596835LEAD 978A133 ISTM SSMRI 2.16MM EMAN GLBL

Trademark Results [InterStim]

Mark Image

Registration | Serial
Company
Trademark
Application Date
INTERSTIM
INTERSTIM
74469362 2072076 Live/Registered
Medtronic, Inc.
1993-12-13

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