GUDID 00643169378452

PROBE SPK1004 SURGEON CONTROLLED ROHS

MEDTRONIC XOMED, INC.

Nerve-locating system, line-powered

• Primary Device ID: 00643169378452
• NIH Device Record Key: 3664c11f-e1b4-4635-b1fc-004ab0c4e0c8
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: SPK1004
• 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: false
• 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
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Dimensions

• Length: 2.5 Meter
• Length: 2.5 Meter
• Length: 2.5 Meter
• Length: 2.5 Meter
• Length: 2.5 Meter
• Length: 2.5 Meter
• Needle Gauge: 27 Gauge
• Length: 13 Millimeter
• Length: 2.5 Meter
• Needle Gauge: 27 Gauge
• Length: 13 Millimeter
• Length: 2.5 Meter
• Needle Gauge: 27 Gauge
• Length: 13 Millimeter
• Length: 2.5 Meter
• Needle Gauge: 27 Gauge
• Length: 13 Millimeter
• Length: 2.5 Meter
• Needle Gauge: 27 Gauge
• Length: 13 Millimeter
• Length: 2.5 Meter
• Needle Gauge: 27 Gauge
• Length: 13 Millimeter
• Length: 2.5 Meter
• Needle Gauge: 27 Gauge
• Length: 13 Millimeter
• Length: 2.5 Meter
• Needle Gauge: 27 Gauge
• Length: 13 Millimeter
• Length: 2.5 Meter
• Needle Gauge: 27 Gauge
• Length: 13 Millimeter
• Length: 2.5 Meter
• Needle Gauge: 27 Gauge
• Length: 13 Millimeter
• Length: 2.5 Meter
• Needle Gauge: 27 Gauge
• Length: 13 Millimeter
• Length: 2.5 Meter
• Needle Gauge: 27 Gauge
• Length: 13 Millimeter
• Length: 2.5 Meter
• Needle Gauge: 27 Gauge
• Length: 13 Millimeter
• Length: 2.5 Meter
• Needle Gauge: 27 Gauge
• Length: 13 Millimeter
• Length: 2.5 Meter
• Needle Gauge: 27 Gauge
• Length: 13 Millimeter
• Length: 2.5 Meter
• Needle Gauge: 27 Gauge
• Length: 13 Millimeter
• Length: 2.5 Meter
• Needle Gauge: 27 Gauge
• Length: 13 Millimeter
• Length: 2.5 Meter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169378452 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061639

FDA Product Code

• IYN: System, imaging, pulsed doppler, ultrasonic

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: 2016-05-05

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