RestoreUltra®SureScan®

GUDID 00643169553125

INS 97712 RSTRULTRA SS MRI EMAN COQUIPUL

MEDTRONIC, INC.

Analgesic spinal cord electrical stimulation system
Primary Device ID00643169553125
NIH Device Record Keya04c6eb3-acc7-4004-b46d-516c82d1e3e7
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
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 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
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 125 Degrees Fahrenheit
Storage Environment TemperatureBetween -18 Degrees Celsius and 52 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 125 Degrees Fahrenheit
Storage Environment TemperatureBetween -18 Degrees Celsius and 52 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 125 Degrees Fahrenheit
Storage Environment TemperatureBetween -18 Degrees Celsius and 52 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 125 Degrees Fahrenheit
Storage Environment TemperatureBetween -18 Degrees Celsius and 52 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 125 Degrees Fahrenheit
Storage Environment TemperatureBetween -18 Degrees Celsius and 52 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 125 Degrees Fahrenheit
Storage Environment TemperatureBetween -18 Degrees Celsius and 52 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 125 Degrees Fahrenheit
Storage Environment TemperatureBetween -18 Degrees Celsius and 52 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 125 Degrees Fahrenheit
Storage Environment TemperatureBetween -18 Degrees Celsius and 52 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 125 Degrees Fahrenheit
Storage Environment TemperatureBetween -18 Degrees Celsius and 52 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 125 Degrees Fahrenheit
Storage Environment TemperatureBetween -18 Degrees Celsius and 52 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 125 Degrees Fahrenheit
Storage Environment TemperatureBetween -18 Degrees Celsius and 52 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 125 Degrees Fahrenheit
Storage Environment TemperatureBetween -18 Degrees Celsius and 52 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 125 Degrees Fahrenheit
Storage Environment TemperatureBetween -18 Degrees Celsius and 52 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 125 Degrees Fahrenheit
Storage Environment TemperatureBetween -18 Degrees Celsius and 52 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 125 Degrees Fahrenheit
Storage Environment TemperatureBetween -18 Degrees Celsius and 52 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 125 Degrees Fahrenheit
Storage Environment TemperatureBetween -18 Degrees Celsius and 52 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169553125 [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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00199150032464 - NA2025-07-21 CUSTOM PACK BB10R35R4 CP PRIME
20199150032482 - NA2025-07-21 CUSTOM PACK 6S19R4 10PK DIALYSIS
00199150033423 - NA2025-07-21 CUSTOM PACK BB12B90R7 SPECTRU
20199150033571 - NA2025-07-21 CUSTOM PACK BB2U59R3 2PK 1/4 TBL L
00199150033614 - NA2025-07-21 CUSTOM PACK BB10J74R14 3/8CNTRIS
00199150034246 - NA2025-07-21 CUSTOM PACK BB11J86R12 ADULT E
00763000925093 - FlexCath Cross™ Transseptal Solution2025-07-21 NDL 900302 FLEXCATH CROSS SL 63CM EIFU

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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