PrimeADVANCED™

GUDID 00613994842312

INS 37702 PRIME ADV eMAN BLUE WRENCH US

MEDTRONIC, INC.

Analgesic spinal cord electrical stimulation system

• Primary Device ID: 00613994842312
• NIH Device Record Key: 6af22ebb-b63b-417b-82b5-2be9b295120f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PrimeADVANCED™
• Version Model Number: 37702
• Company DUNS: 796986144
• Company Name: MEDTRONIC, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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

Operating and Storage Conditions

• Handling Environment Temperature: Between -18 Degrees Celsius and 52 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 52 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 52 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 52 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 52 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 126 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994842312 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2014-09-23

Devices Manufactured by MEDTRONIC, INC.

• 00763000990534 - NA: 2024-12-31 CUSTOM PACK SSBB12H98R5 ADULT PACK
• 00763000989903 - NA: 2024-12-30 CUSTOM PACK BB12H87R2 3/8 E PACK
• 00763000989729 - NA: 2024-12-27 CUSTOM PACK BB8S01R5 CITRS AVL
• 20763000989754 - NA: 2024-12-27 CUSTOM PACK BB12G31R2 4PK ENOE CPL
• 20763000989846 - NA: 2024-12-27 CUSTOM PACK BB11L70R1 4PK CP 2013
• 00763000708917 - DiamondTemp™ FASTR RF Generator: 2024-12-23 GENERATOR CEDTG200 FASTR RF US
• 00763000709051 - DiamondTemp™ Irrigation Pump: 2024-12-23 IRRIGATION PUMP CEDTP100 US
• 00763000989156 - NA: 2024-12-23 CUSTOM PACK BB11C49R9 1/4 PACK