GUDID 00613994188335

STIMULATOR 37021 EXTERNAL ADVANCED EN

MEDTRONIC, INC.

Analgesic spinal cord electrical stimulation system

• Primary Device ID: 00613994188335
• NIH Device Record Key: cb551d25-3b7e-4866-875e-8aec15182567
• Commercial Distribution Discontinuation: 2018-09-26
• Commercial Distribution Status: Not in Commercial Distribution
• Version Model Number: 37021
• 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: false
• 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

Operating and Storage Conditions

• Handling Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994188335 [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: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-10-02
• Device Publish Date: 2014-09-23

Devices Manufactured by MEDTRONIC, INC.

• 00199150060467 - NA: 2025-11-28 CUSTOM PACK BB11Q49R14 EVL 3/8 EC
• 00199150060627 - NA: 2025-11-28 CUSTOM PACK BB12M28R9 HLO QHLM-FROS
• 00199150057177 - NA: 2025-11-24 CUSTOM PACK BB3Z71R34 HLO PRIMARY
• 00199150058976 - NA: 2025-11-24 CUSTOM PACK PDBB12P71R2 HLO HEATT
• 00199150060122 - NA: 2025-11-24 CUSTOM PACK BB12S52R1 EVL 3/8 PACK
• 00763000849801 - Liberant™: 2025-11-24 CONSOLE LMT-BCU LIBERANT
• 00763000913069 - InterStim™ SureScan™: 2025-11-24 LEAD 978A128 ISTM 2.16MM EUMDR EMAN LI08
• 00763000913083 - InterStim™ SureScan™: 2025-11-24 LEAD 978A133 ISTM 2.16MM EMAN EUMDR LI08