InterStim™ Micro SureScan™ MRI

GUDID 00763000596736

INS 97810 ISTM MICRO SSMRI RC EMAN US

MEDTRONIC, INC.

Implantable incontinence-control electrical stimulation system pulse generator
Primary Device ID00763000596736
NIH Device Record Key72feed16-ff50-4cdb-8313-aba1bce3eb85
Commercial Distribution StatusIn Commercial Distribution
Brand NameInterStim™ Micro SureScan™ MRI
Version Model Number97810
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 Batchfalse
Serial Numbertrue
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000596736 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QONImplanted electrical device intended for treatment of fecal incontinence

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-06-13
Device Publish Date2022-06-05

Devices Manufactured by MEDTRONIC, INC.

00199150042005 - NA2025-08-29 CUSTOM PACK BB7E29R28 EVL 3/8
00199150042012 - NA2025-08-29 CUSTOM PACK BB11L88R8 EVL SUPPRT SM
00199150042029 - NA2025-08-29 CUSTOM PACK BB12P62R3 EVL 1/4
00199150042043 - NA2025-08-29 CUSTOM PACK BB9E98R16 EVL WCH PED
00199150042067 - NA2025-08-29 CUSTOM PACK BB7E31R31 EVL 1 EVT 1/4
00199150042739 - NA2025-08-29 CUSTOM PACK BB7V67R13 HLO PRESBY
00199150042746 - NA2025-08-29 CUSTOM PACK BB0C00R32 EVL 3/8SUPPT
00763000658960 - Profile 3D™2025-08-29 HANDLE 7686L ANNULOPLASTY2 MDR

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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