GUDID 20643169294374

ELECTRODE 8227304 5PK PRASS PR 18MM ROHS

MEDTRONIC XOMED, INC.

Electromyographic needle electrode, single-use

• Primary Device ID: 20643169294374
• NIH Device Record Key: b6df0bec-32e1-4362-a2fc-031f453c08fb
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 8227304
• 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

Device Dimensions

• Length: 18 Millimeter
• Length: 18 Millimeter
• Length: 18 Millimeter
• Length: 18 Millimeter
• Length: 18 Millimeter
• Length: 18 Millimeter
• Length: 18 Millimeter
• Length: 18 Millimeter
• Length: 18 Millimeter
• Length: 18 Millimeter
• Length: 18 Millimeter
• Length: 18 Millimeter
• Length: 18 Millimeter
• Length: 18 Millimeter
• Length: 18 Millimeter
• Length: 18 Millimeter
• Length: 18 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169294370 [Primary]
GS1	20643169294374 [Package]; Contains: 00643169294370; Package: PK [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K002992

FDA Product Code

• FMI: Needle, hypodermic, single lumen

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: 2018-07-06
• Device Publish Date: 2016-04-22

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