RestoreSensor

GUDID 00613994610430

INS 37714 SENSOR US MARKET

MEDTRONIC, INC.

Analgesic spinal cord electrical stimulation system
Primary Device ID00613994610430
NIH Device Record Keyd8c6c356-ffe8-4a68-891e-2042da2f8e11
Commercial Distribution StatusIn Commercial Distribution
Brand NameRestoreSensor
Version Model Number37714
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

Operating and Storage Conditions

Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 126 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 126 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 126 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 126 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100613994610430 [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 Number3
Public Version Date2018-07-06
Device Publish Date2014-09-23

Devices Manufactured by MEDTRONIC, INC.

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20763000975016 - NA2024-09-17 CUSTOM PACK BB10M39R3 10PK VAMP/ACC
00763000975197 - NA2024-09-17 CUSTOM PACK BB8G55R17 A PACK
00763000974190 - NA2024-09-16 CUSTOM PACK HY9L80R7 SADT FUS
00763000974251 - NA2024-09-16 CUSTOM PACK HY4D49R18 LEFT HBY
00763000975135 - NA2024-09-16 CUSTOM PACK BB12G92R4 L PEDI/S ADUL
00763000974572 - NA2024-09-10 CUSTOM PACK BB3X42R20 UNV
20763000181080 - NA2024-09-09 CABLE 5833SL SURGICAL5PK DISP

Trademark Results [RestoreSensor]

Mark Image

Registration | Serial
Company
Trademark
Application Date
RESTORESENSOR
RESTORESENSOR
77503050 4109086 Live/Registered
Medtronic, Inc.
2008-06-19

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