GUDID 00763000239305

CONTROLLER 97745 INTELLIS PTM FA

MEDTRONIC, INC.

Multiple active implantable device programmer
Primary Device ID00763000239305
NIH Device Record Keybec12071-0138-4863-8310-66801ac0dcc3
Commercial Distribution StatusIn Commercial Distribution
Version Model Number97745FA
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 Kitfalse
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

Operating and Storage Conditions

Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment TemperatureBetween -30 Degrees Celsius and 58 Degrees Celsius
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment TemperatureBetween -30 Degrees Celsius and 58 Degrees Celsius
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment TemperatureBetween -30 Degrees Celsius and 58 Degrees Celsius
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment TemperatureBetween -30 Degrees Celsius and 58 Degrees Celsius
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment TemperatureBetween -30 Degrees Celsius and 58 Degrees Celsius
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment TemperatureBetween -30 Degrees Celsius and 58 Degrees Celsius
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment TemperatureBetween -30 Degrees Celsius and 58 Degrees Celsius
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment TemperatureBetween -30 Degrees Celsius and 58 Degrees Celsius
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment TemperatureBetween -30 Degrees Celsius and 58 Degrees Celsius
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment TemperatureBetween -30 Degrees Celsius and 58 Degrees Celsius
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment TemperatureBetween -30 Degrees Celsius and 58 Degrees Celsius
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment TemperatureBetween -30 Degrees Celsius and 58 Degrees Celsius
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 136 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000239305 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LGWSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-07-02
Device Publish Date2019-06-24

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