GUDID 00763000292096

COMM HANDSET KIT TH91D01 DBS US PPR EN

MEDTRONIC, INC.

Multiple active implantable device programmer
Primary Device ID00763000292096
NIH Device Record Keycf0b74a4-a4e6-4795-a95f-2ec89637875c
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberTH91D01
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000292096 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MHYStimulator, electrical, implanted, for parkinsonian tremor

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-13
Device Publish Date2020-07-05

Devices Manufactured by MEDTRONIC, INC.

00199150009114 - NA2025-09-15 CUSTOM PACK BB10Z98R7 PED E
00199150044467 - NA2025-09-15 CUSTOM PACK BB0F74R12 L SUPPORT
00199150044498 - NA2025-09-15 CUSTOM PACK BB12M12R5 CPB
20199150044515 - NA2025-09-15 CUSTOM PACK BB12N37R1 5PK LOWER LMB
00199150044641 - NA2025-09-15 CUSTOM PACK BB12P94R2 EVL IOM SUPPO
00199150044658 - NA2025-09-15 CUSTOM PACK SSBB12R80R HLN
00199150044665 - NA2025-09-15 CUSTOM PACK BB12E50R5 HLO SPECT PUM
20199150045222 - NA2025-09-15 CUSTOM PACK 12R69R 10PK EVL

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