RestoreAdvanced®SureScan®

GUDID 00643169553132

INS 97713 RSTORADVN SS MRI EMAN COQUIPUL

MEDTRONIC, INC.

Analgesic spinal cord electrical stimulation system
Primary Device ID00643169553132
NIH Device Record Key4f186105-40f1-405b-9172-308e988e879c
Commercial Distribution StatusIn Commercial Distribution
Brand NameRestoreAdvanced®SureScan®
Version Model Number97713
Company DUNS796986144
Company NameMEDTRONIC, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
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

Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 125 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 125 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 125 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 125 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169553132 [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 Date2016-05-08

Devices Manufactured by MEDTRONIC, INC.

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00199150026692 - NA2025-06-27 CUSTOM PACK BB8R73R14 NH ADULT PACK
00199150026715 - NA2025-06-27 CUSTOM PACK BB6M71R12 CP PRIME
00199150026746 - NA2025-06-27 CUSTOM PACK BB7A25R12 PED
00199150026753 - NA2025-06-27 CUSTOM PACK BB12E34R4 SUPPORT PACK

Trademark Results [RestoreAdvanced]

Mark Image

Registration | Serial
Company
Trademark
Application Date
RESTOREADVANCED
RESTOREADVANCED
78709749 3204643 Live/Registered
Medtronic, Inc.
2005-09-09

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