GUDID 20643169938551

ELECTRODE 8227133 25PK NDL 1.5MM VI ROHS

MEDTRONIC XOMED, INC.

Subdermal needle electrode Subdermal needle electrode Subdermal needle electrode Subdermal needle electrode Subdermal needle electrode Subdermal needle electrode Subdermal needle electrode Subdermal needle electrode Subdermal needle electrode Subdermal needle electrode Subdermal needle electrode Subdermal needle electrode Subdermal needle electrode Subdermal needle electrode Subdermal needle electrode Subdermal needle electrode Subdermal needle electrode Subdermal needle electrode

• Primary Device ID: 20643169938551
• NIH Device Record Key: 71fac952-ff12-4109-a2a9-ba82437ae57f
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 8227133
• Company DUNS: 835465063
• Company Name: MEDTRONIC XOMED, 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
• 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
• 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
• 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
• 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
• 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 Dimensions

• Length: 1.5 Millimeter
• Length: 1.5 Millimeter
• Length: 1.5 Millimeter
• Length: 1.5 Millimeter
• Length: 1.5 Millimeter
• Length: 1.5 Millimeter
• Length: 1.5 Millimeter
• Length: 1.5 Millimeter
• Length: 1.5 Millimeter
• Length: 1.5 Millimeter
• Length: 1.5 Millimeter
• Length: 1.5 Millimeter
• Length: 1.5 Millimeter
• Length: 1.5 Millimeter
• Length: 1.5 Millimeter
• Length: 1.5 Millimeter
• Length: 1.5 Millimeter
• Length: 1.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169938557 [Primary]
GS1	20643169938551 [Package]; Contains: 00643169938557; Package: PK [25 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K850107

FDA Product Code

• GXZ: ELECTRODE, NEEDLE

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-03-26

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