COMM HANDSET TH90Q01 ISTIM X EMAN US Medical Device Identification

GUDID 00763000825997

COMM HANDSET TH90Q01 ISTIM X EMAN US

MEDTRONIC, INC.

Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer

Primary Device ID	00763000825997
NIH Device Record Key	ef5bae3e-30c8-4c3d-9a89-7f27ae63b0f6
Commercial Distribution Status	In Commercial Distribution
Version Model Number	TH90Q01
Company DUNS	796986144
Company Name	MEDTRONIC, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	true
Device Combination Product	false
Single Use	false
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
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	00763000825997 [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	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2023-04-17
Device Publish Date	2023-04-07

Devices Manufactured by MEDTRONIC, INC.

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00763000902544 - Launcher™	2024-06-04 CATHETER LA83DRCSH LA 8F 100CM 3DRC
00763000902551 - Launcher™	2024-06-04 CATHETER LA83DRCSHD LA 8F 90CM 3DRC
00763000902568 - Launcher™	2024-06-04 CATHETER LA83DRIGHT LA 8F 100CM 3DRGT
00763000902575 - Launcher™	2024-06-04 CATHETER LA83DRIGHTD LA 8F 90CM 3DRGT
00763000902582 - Launcher™	2024-06-04 CATHETER LA8AL10 LA 8F 100CM AL10
00763000902599 - Launcher™	2024-06-04 CATHETER LA8AL10D LA 8F 90CM AL10
00763000902605 - Launcher™	2024-06-04 CATHETER LA8AL10F LA 8F 80CM AL10