GUDID 00763000875770

CNTRL 97745-RFB INTELLIS PTM REFURB US

MEDTRONIC, INC.

Multiple active implantable device programmer
Primary Device ID00763000875770
NIH Device Record Keyd40fc4ec-5aea-4eaf-9bf8-9321fc79364f
Commercial Distribution StatusIn Commercial Distribution
Version Model Number97745-RFB
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
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 -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
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
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000875770 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QRBStimulator, spinal-cord, totally implanted for relief of pain due to diabetic neuropathy

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-24
Device Publish Date2023-11-16

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