RestoreUltra® SureScan®

GUDID 00643169109506

INS 97712 RESTORE ULTRA MRICS

MEDTRONIC, INC.

Analgesic spinal cord electrical stimulation system
Primary Device ID00643169109506
NIH Device Record Keydd358a9b-a78b-4949-950f-9dcac2e8899e
Commercial Distribution StatusIn Commercial Distribution
Brand NameRestoreUltra® SureScan®
Version Model Number97712
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

Handling Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Handling Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Handling Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Handling Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169109506 [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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00199150026579 - NA2025-06-27 CUSTOM PACK BB5722R48 CHRT INF
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 [RestoreUltra]

Mark Image

Registration | Serial
Company
Trademark
Application Date
RESTOREULTRA
RESTOREULTRA
78903139 3433265 Live/Registered
Medtronic, Inc.
2006-06-07

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