RestoreULTRA™

GUDID 00613994842343

INS 37712 RESTOREULTRA eMAN BLU WRNCH US

MEDTRONIC, INC.

Deep brain electrical stimulation system Deep brain electrical stimulation system

• Primary Device ID: 00613994842343
• NIH Device Record Key: 3edbc1c1-3213-486c-ac3a-29dd8687781c
• Commercial Distribution Discontinuation: 2018-08-13
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: RestoreULTRA™
• Version Model Number: 37712
• 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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994842343 [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: 4
• Public Version Date: 2018-10-02
• Device Publish Date: 2014-09-23

On-Brand Devices [RestoreULTRA™]

• 00613994842343: INS 37712 RESTOREULTRA eMAN BLU WRNCH US
• 00613994842336: INS 37712 RESTORE ULTRA BLUE WRENCH US