Accuguide®

GUDID 00613994161635

SOFTWARE 8263005 ACCUGUIDE MONIT V2.0 CD

MEDTRONIC XOMED, INC.

Nerve-locating system Nerve-locating system

• Primary Device ID: 00613994161635
• NIH Device Record Key: 10b21145-dc96-4a30-ac6c-5a14c740d4b5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Accuguide®
• Version Model Number: 8263005
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994161635 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K990793

FDA Product Code

• IKN: Electromyograph, diagnostic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-04-29

On-Brand Devices [Accuguide®]

• 00613994161635: SOFTWARE 8263005 ACCUGUIDE MONIT V2.0 CD
• 20643169345007: NEEDLE 8263211 5PK 27G W/ELECTRODE ROHS
• 20643169344994: NEEDLE 8263210 5PK 30G W/ELECTRODE ROHS