GUDID 00763000927547

COMM HANDSET TH90Q01 ISTIM X A13 EMAN US

MEDTRONIC, INC.

Multiple active implantable device programmer
Primary Device ID00763000927547
NIH Device Record Key4c8eda5e-476e-4b73-bb25-32f0eb0248de
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberTH90Q01
Company DUNS796986144
Company NameMEDTRONIC, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
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
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
GS100763000927547 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EZWStimulator, electrical, implantable, for incontinence

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-06-11
Device Publish Date2024-06-03

Devices Manufactured by MEDTRONIC, INC.

00199150006434 - NA2025-04-22 CUSTOM PACK BB11P23R4 LARGO DUAL V
00199150006465 - NA2025-04-22 CUSTOM PACK BB12E01R8 MAINPCK
00199150006618 - NA2025-04-22 CUSTOM PACK BB6N93R9 OSF ADPTR
00199150006861 - NA2025-04-22 CUSTOM PACK BB6Y28R11 CMAG L I V
00199150006878 - NA2025-04-22 CUSTOM PACK BB6Y37R3 CP PRIME
20199150006896 - NA2025-04-22 CUSTOM PACK BB10Y97R1 5PK MANIFOLD
20199150006919 - NA2025-04-22 CUSTOM PACK BB10Y99R1 10PK ARTERIAL Y
00199150006922 - NA2025-04-22 CUSTOM PACK BB11Q27R2 MANIFOLD

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.