GUDID 00643169887428

ACCY KIT 3550-02 WRENCH/SCREWS US FWU

MEDTRONIC, INC.

Neurosurgical procedure kit, non-medicated, single-use Neurosurgical procedure kit, non-medicated, single-use Neurosurgical procedure kit, non-medicated, single-use

• Primary Device ID: 00643169887428
• NIH Device Record Key: 460f7330-6c9b-41d6-ab87-93986cee12e1
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 3550-02
• 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
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169887428 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K960631

FDA Product Code

• GZF: STIMULATOR, PERIPHERAL NERVE, IMPLANTED (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: 2017-10-20

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