RestoreSensor™SureScan®

GUDID 00643169109483

INS 97714 RESTORE SENSOR MRICS

MEDTRONIC, INC.

Analgesic spinal cord electrical stimulation system
Primary Device ID00643169109483
NIH Device Record Key4d0a1c6f-8db8-4987-8eff-46d2c3e1c382
Commercial Distribution StatusIn Commercial Distribution
Brand NameRestoreSensor™SureScan®
Version Model Number97714
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 -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment TemperatureBetween -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment TemperatureBetween -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment TemperatureBetween -30 Degrees Fahrenheit and 135 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169109483 [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.

00199150021055 - NA2025-06-06 CUSTOM PACK BB11B15R1 CHP CIRCUIT
00199150021062 - NA2025-06-06 CUSTOM PACK BB11F90R3 ADULT ECC3/8
00199150021079 - NA2025-06-06 CUSTOM PACK BB7C59R10 E C L S
20199150021110 - NA2025-06-06 CUSTOM PACK BB6X07R3 2PK 38 E
20199150021134 - NA2025-06-06 CUSTOM PACK BB12A97R1 5PK PIGTAIL
00199150021147 - NA2025-06-06 CUSTOM PACK BB10Z01R17 SUPPORT PACK
20199150021165 - NA2025-06-06 CUSTOM PACK BB10Y40R1 5PK BRIDGE PACK
20199150021653 - NA2025-06-06 CUSTOM PACK BB12D52R2 10PK 3/16 BRIDGE

Trademark Results [RestoreSensor]

Mark Image

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

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.