COMM HANDSET TH90QFA ISTIM X EMAN US Medical Device Identification

GUDID 00763000826000

COMM HANDSET TH90QFA 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	00763000826000
NIH Device Record Key	244d366f-db68-40d0-bc05-5f2c8e005534
Commercial Distribution Status	In Commercial Distribution
Version Model Number	TH90QFA
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	00763000826000 [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.

00763000894689 - SHERPA NX BALANCED™	2024-06-07 CATHETER SB6MP1K SB 6F 55CM MP1
00763000894726 - SHERPA NX BALANCED™	2024-06-07 CATHETER SB6MPHK SB 55CM MPH
00763000894801 - SHERPA NX BALANCED™	2024-06-07 CATHETER SB6PK1W SB 6F 47CM PK1
00763000894917 - SHERPA NX BALANCED™	2024-06-07 CATHETER SB6RDCK SB 6F 55CM RDC
00763000895754 - SHERPA NX BALANCED™	2024-06-07 CATHETER SB7IMAK SB 7F 55CM IMA
00763000901905 - Launcher™	2024-06-07 CATHETER LA8NOTOSH LA 8F 100CM NOTO
00763000902230 - Launcher™	2024-06-07 CATHETER LA8SCR35SH LA 8F 100CM SCR35
00763000902520 - Launcher™	2024-06-07 CATHETER LA83DRC LA 8F 100CM 3DRC