GUDID 00643169660076

ACCY 355018 LEAD INTRODUCR KIT ISTIM US

MEDTRONIC, INC.

Neurosurgical procedure kit, non-medicated, single-use

• Primary Device ID: 00643169660076
• NIH Device Record Key: 4522bc37-4d91-4f10-8143-4ea6aa61c381
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 355018
• 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: true
• Serial Number: false
• 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 -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Storage Environment Temperature: Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Storage Environment Temperature: Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Storage Environment Temperature: Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169660076 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K013120

FDA Product Code

• GZB: STIMULATOR, SPINAL-CORD, IMPLANTED (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: 2018-08-01
• Device Publish Date: 2018-07-01

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