PrimeAdvanced® SureScan® MRI

GUDID 00763000315481

INS 97702 PRIMEADV MRI EMAN GRC 2.0

MEDTRONIC, INC.

Analgesic spinal cord electrical stimulation system pulse generator, implantable Analgesic spinal cord electrical stimulation system pulse generator, implantable Analgesic spinal cord electrical stimulation system pulse generator, implantable Analgesic spinal cord electrical stimulation system pulse generator, implantable Analgesic spinal cord electrical stimulation system pulse generator, implantable Analgesic spinal cord electrical stimulation system pulse generator, implantable Analgesic spinal cord electrical stimulation system pulse generator, implantable Analgesic spinal cord electrical stimulation system pulse generator, implantable Analgesic spinal cord electrical stimulation system pulse generator, implantable Analgesic spinal cord electrical stimulation system pulse generator, implantable Analgesic spinal cord electrical stimulation system pulse generator, implantable Analgesic spinal cord electrical stimulation system pulse generator, implantable Analgesic spinal cord electrical stimulation system pulse generator, implantable Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable
Primary Device ID00763000315481
NIH Device Record Keydea0a881-f3e8-491e-87fd-e992a9077438
Commercial Distribution StatusIn Commercial Distribution
Brand NamePrimeAdvanced® SureScan® MRI
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
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
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
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 -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
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 -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
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 125 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000315481 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-10-06
Device Publish Date2020-09-28

On-Brand Devices [PrimeAdvanced® SureScan® MRI]

00643169974883INS 97702 PRIMEADV SURESCAN MRI EMAN GRC
00763000315481INS 97702 PRIMEADV MRI EMAN GRC 2.0

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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