PrimeAdvanced® SureScan® MRI

GUDID 00643169974883

INS 97702 PRIMEADV SURESCAN MRI EMAN GRC

MEDTRONIC, INC.

Analgesic spinal cord electrical stimulation system

• Primary Device ID: 00643169974883
• NIH Device Record Key: a7023e6b-e624-47f8-96be-29221844168f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PrimeAdvanced® SureScan® MRI
• Version Model Number: 97702
• Company DUNS: 796986144
• Company Name: MEDTRONIC, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Storage Environment Temperature: Between -18 Degrees Celsius and 52 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Storage Environment Temperature: Between -18 Degrees Celsius and 52 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Storage Environment Temperature: Between -18 Degrees Celsius and 52 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Storage Environment Temperature: Between -18 Degrees Celsius and 52 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Storage Environment Temperature: Between -18 Degrees Celsius and 52 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Storage Environment Temperature: Between -18 Degrees Celsius and 52 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Storage Environment Temperature: Between -18 Degrees Celsius and 52 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Storage Environment Temperature: Between -18 Degrees Celsius and 52 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Storage Environment Temperature: Between -18 Degrees Celsius and 52 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Storage Environment Temperature: Between -18 Degrees Celsius and 52 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Storage Environment Temperature: Between -18 Degrees Celsius and 52 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Storage Environment Temperature: Between -18 Degrees Celsius and 52 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Storage Environment Temperature: Between -18 Degrees Celsius and 52 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Storage Environment Temperature: Between -18 Degrees Celsius and 52 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Storage Environment Temperature: Between -18 Degrees Celsius and 52 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Storage Environment Temperature: Between -18 Degrees Celsius and 52 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169974883 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P840001

FDA Product Code

• LGW: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-02-25
• Device Publish Date: 2019-01-25

On-Brand Devices [PrimeAdvanced® SureScan® MRI]

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