PrimeAdvanced® SureScan®

GUDID 00643169109513

INS 97702 RESTORE PRIME ADVANCED MRICS

MEDTRONIC, INC.

Analgesic spinal cord electrical stimulation system Analgesic spinal cord electrical stimulation system
Primary Device ID00643169109513
NIH Device Record Keyd9c16bc3-1ac3-4483-b136-2d5870d9753b
Commercial Distribution StatusIn Commercial Distribution
Brand NamePrimeAdvanced® SureScan®
Version Model Number97702
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 -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
Handling Environment TemperatureBetween -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
Handling Environment TemperatureBetween -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
Handling Environment TemperatureBetween -30 Degrees Fahrenheit and 135 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169109513 [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.

20763000825212 - NA2024-03-25 CUSTOM PACK SS12B17R1 5PK CHANGEOUT
00763000825324 - NA2024-03-25 78.800
00763000940300 - NA2024-03-25 CUSTOM PACK BB6H26R45 ADULT CK
00763000941055 - NA2024-03-25 CUSTOM PACK HY9M47R20 ADLT MAIN
20763000941073 - NA2024-03-25 CUSTOM PACK BB12G07R 5PK ACC LINE
00763000941086 - NA2024-03-25 CUSTOM PACK BB12F62R2 UOFU HEART PA
00763000941093 - NA2024-03-25 CUSTOM PACK HY8B05R11 HBC
00763000941352 - NA2024-03-25 CUSTOM PACK BB12F31R E TRANS

Trademark Results [PrimeAdvanced]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PRIMEADVANCED
PRIMEADVANCED
78709773 3204644 Live/Registered
Medtronic, Inc.
2005-09-09

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