GUDID 00763000278762

ENS 97725 WIRELESS INTELLIS US EMAN

MEDTRONIC, INC.

Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, external
Primary Device ID00763000278762
NIH Device Record Key6f8c5895-d699-4468-89d0-e876b082b9b3
Commercial Distribution StatusIn Commercial Distribution
Version Model Number97725
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 Usetrue
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

Operating and Storage Conditions

Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 129 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 54 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 129 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 54 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 129 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 54 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 129 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 54 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 129 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 54 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 129 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 54 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 129 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 54 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 129 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 54 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 129 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 54 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 129 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 54 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 129 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 54 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 129 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 54 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 129 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 54 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 129 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 54 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 129 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 54 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 129 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 54 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 129 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 54 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 129 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 54 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 129 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 54 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 129 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 54 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 129 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 54 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 129 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 54 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 129 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 54 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 129 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 54 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 129 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 54 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 129 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 54 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 129 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 54 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 129 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 54 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 129 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 54 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 129 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 54 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000278762 [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 Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-02-15
Device Publish Date2021-02-06

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