InterStim™ X

GUDID 00763000484668

INS 97800 INTERSTIM X SSMRI AMER

MEDTRONIC, INC.

Implantable incontinence-control electrical stimulation system pulse generator Implantable incontinence-control electrical stimulation system pulse generator Implantable incontinence-control electrical stimulation system pulse generator Implantable incontinence-control electrical stimulation system pulse generator Implantable incontinence-control electrical stimulation system pulse generator Implantable incontinence-control electrical stimulation system pulse generator Implantable incontinence-control electrical stimulation system pulse generator Implantable incontinence-control electrical stimulation system pulse generator Implantable incontinence-control electrical stimulation system pulse generator Implantable incontinence-control electrical stimulation system pulse generator Implantable incontinence-control electrical stimulation system pulse generator Implantable incontinence-control electrical stimulation system pulse generator
Primary Device ID00763000484668
NIH Device Record Key6038a088-5a91-47bc-aa1d-33ba2e5e9f85
Commercial Distribution StatusIn Commercial Distribution
Brand NameInterStim™ X
Version Model Number97800
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
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
GS100763000484668 [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 Date2022-03-14
Device Publish Date2022-03-04

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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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