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 ID	00763000484668
NIH Device Record Key	6038a088-5a91-47bc-aa1d-33ba2e5e9f85
Commercial Distribution Status	In Commercial Distribution
Brand Name	InterStim™ X
Version Model Number	97800
Company DUNS	796986144
Company Name	MEDTRONIC, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	MR Conditional
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	false
Serial Number	true
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000484668 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Approval: P080025

FDA Product Code

QON	Implanted electrical device intended for treatment of fecal incontinence

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2022-03-14
Device Publish Date	2022-03-04

Devices Manufactured by MEDTRONIC, INC.

00763000951825 - NA	2024-05-31 CUSTOM PACK SSBB12G88R STERILE SMPL
00763000953423 - NA	2024-05-31 CUSTOM PACK BB12F51R2 E ASSIST PACK
00763000953614 - NA	2024-05-31 CUSTOM PACK HY0A20R46 CHRST NN
00763000953621 - NA	2024-05-31 CUSTOM PACK BB11Q49R11 3/8 EC
00763000953638 - NA	2024-05-31 CUSTOM PACK BB12A45R1 SMALL LOOP
00763000953645 - NA	2024-05-31 CUSTOM PACK BB12A44R2 LRG AV LOOP
20763000953663 - NA	2024-05-31 CUSTOM PACK BB12G60R 2PK 2PK CHRST TBL
00763000953676 - NA	2024-05-31 CUSTOM PACK BB7B00R26 UW CMAG PK

Trademark Results [InterStim]

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