GUDID 00763000017248

ACCY 37500301 PAIN ENS BOOT GLOBAL

MEDTRONIC, INC.

Personal device holder, single-use
Primary Device ID00763000017248
NIH Device Record Key49dac425-16b5-49e7-b1dd-c4a05676856d
Commercial Distribution StatusIn Commercial Distribution
Version Model Number37500301
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 Batchtrue
Serial Numberfalse
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
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 -31 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment TemperatureBetween -31 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment TemperatureBetween -31 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment TemperatureBetween -31 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment TemperatureBetween -35 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -31 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment TemperatureBetween -35 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -31 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment TemperatureBetween -35 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -31 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment TemperatureBetween -35 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -31 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment TemperatureBetween -35 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -31 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment TemperatureBetween -35 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -31 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment TemperatureBetween -35 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -31 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment TemperatureBetween -35 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -31 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment TemperatureBetween -35 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -31 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment TemperatureBetween -35 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -31 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment TemperatureBetween -35 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -31 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment TemperatureBetween -35 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -31 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment TemperatureBetween -35 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -31 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment TemperatureBetween -35 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -31 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment TemperatureBetween -35 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -31 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment TemperatureBetween -35 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -31 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment TemperatureBetween -35 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -31 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment TemperatureBetween -35 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -31 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment TemperatureBetween -35 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -31 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment TemperatureBetween -35 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -31 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment TemperatureBetween -35 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -31 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment TemperatureBetween -35 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -31 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment TemperatureBetween -35 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -31 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment TemperatureBetween -35 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -31 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment TemperatureBetween -35 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -31 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment TemperatureBetween -35 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -31 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment TemperatureBetween -35 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -31 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment TemperatureBetween -35 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -31 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment TemperatureBetween -35 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -31 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment TemperatureBetween -31 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment TemperatureBetween -35 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -31 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment TemperatureBetween -35 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -31 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment TemperatureBetween -35 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -31 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment TemperatureBetween -35 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -31 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment TemperatureBetween -35 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -31 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment TemperatureBetween -35 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -31 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment TemperatureBetween -35 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -31 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment TemperatureBetween -35 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -31 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment TemperatureBetween -35 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -31 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment TemperatureBetween -35 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -31 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment TemperatureBetween -35 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -31 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment TemperatureBetween -35 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -31 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment TemperatureBetween -35 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -31 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment TemperatureBetween -35 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -31 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment TemperatureBetween -35 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -31 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment TemperatureBetween -35 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -31 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment TemperatureBetween -35 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -31 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment TemperatureBetween -35 Degrees Celsius and 57 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000017248 [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 StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-12-11
Device Publish Date2018-05-14

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