GUDID 00763000292089

COMM HANDSET KIT TH90D01 DBS US PPR EN

MEDTRONIC, INC.

Multiple active implantable device programmer
Primary Device ID00763000292089
NIH Device Record Keyd711623d-6771-4a4e-906f-5e5dbb933267
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberTH90D01
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
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

Operating and Storage Conditions

Storage Environment TemperatureBetween -35 Degrees Celsius and 58 Degrees Celsius
Storage Environment TemperatureBetween -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment TemperatureBetween -35 Degrees Celsius and 58 Degrees Celsius
Storage Environment TemperatureBetween -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment TemperatureBetween -35 Degrees Celsius and 58 Degrees Celsius
Storage Environment TemperatureBetween -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment TemperatureBetween -35 Degrees Celsius and 58 Degrees Celsius
Storage Environment TemperatureBetween -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment TemperatureBetween -35 Degrees Celsius and 58 Degrees Celsius
Storage Environment TemperatureBetween -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment TemperatureBetween -35 Degrees Celsius and 58 Degrees Celsius
Storage Environment TemperatureBetween -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment TemperatureBetween -35 Degrees Celsius and 58 Degrees Celsius
Storage Environment TemperatureBetween -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment TemperatureBetween -35 Degrees Celsius and 58 Degrees Celsius
Storage Environment TemperatureBetween -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment TemperatureBetween -35 Degrees Celsius and 58 Degrees Celsius
Storage Environment TemperatureBetween -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment TemperatureBetween -35 Degrees Celsius and 58 Degrees Celsius
Storage Environment TemperatureBetween -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment TemperatureBetween -35 Degrees Celsius and 58 Degrees Celsius
Storage Environment TemperatureBetween -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment TemperatureBetween -35 Degrees Celsius and 58 Degrees Celsius
Storage Environment TemperatureBetween -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment TemperatureBetween -35 Degrees Celsius and 58 Degrees Celsius
Storage Environment TemperatureBetween -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment TemperatureBetween -35 Degrees Celsius and 58 Degrees Celsius
Storage Environment TemperatureBetween -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment TemperatureBetween -35 Degrees Celsius and 58 Degrees Celsius
Storage Environment TemperatureBetween -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment TemperatureBetween -35 Degrees Celsius and 58 Degrees Celsius
Storage Environment TemperatureBetween -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment TemperatureBetween -35 Degrees Celsius and 58 Degrees Celsius
Storage Environment TemperatureBetween -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment TemperatureBetween -35 Degrees Celsius and 58 Degrees Celsius
Storage Environment TemperatureBetween -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment TemperatureBetween -35 Degrees Celsius and 58 Degrees Celsius
Storage Environment TemperatureBetween -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment TemperatureBetween -35 Degrees Celsius and 58 Degrees Celsius
Storage Environment TemperatureBetween -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment TemperatureBetween -35 Degrees Celsius and 58 Degrees Celsius
Storage Environment TemperatureBetween -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment TemperatureBetween -35 Degrees Celsius and 58 Degrees Celsius
Storage Environment TemperatureBetween -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment TemperatureBetween -35 Degrees Celsius and 58 Degrees Celsius
Storage Environment TemperatureBetween -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment TemperatureBetween -35 Degrees Celsius and 58 Degrees Celsius
Storage Environment TemperatureBetween -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment TemperatureBetween -35 Degrees Celsius and 58 Degrees Celsius
Storage Environment TemperatureBetween -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment TemperatureBetween -35 Degrees Celsius and 58 Degrees Celsius
Storage Environment TemperatureBetween -31 Degrees Fahrenheit and 136 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000292089 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MBXSTIMULATOR, THALAMIC, EPILEPSY, IMPLANTED

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.

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