GUDID 00613994609915

PROG 37754 SENSOR INSR US MARKET

MEDTRONIC, INC.

Noninvasive device battery charger Noninvasive device battery charger
Primary Device ID00613994609915
NIH Device Record Key9ac20a03-fdd7-4f09-9994-4b910f097912
Commercial Distribution Discontinuation2018-08-13
Commercial Distribution StatusNot in Commercial Distribution
Version Model Number37754
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

Operating and Storage Conditions

Handling Environment TemperatureBetween -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween -4 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100613994609915 [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 StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2020-02-06
Device Publish Date2014-09-23

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