APS™

GUDID 00643169309333

ELECTRODE 8228053 APS 3MM ROHS

MEDTRONIC XOMED, INC.

Nerve-locating system Nerve-locating system

• Primary Device ID: 00643169309333
• NIH Device Record Key: 6faa1a3b-56f5-424c-86f3-836dc27dc2b0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: APS™
• Version Model Number: 8228053
• 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

Device Dimensions

• Outer Diameter: 3 Millimeter
• Outer Diameter: 3 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169309333 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083124

FDA Product Code

• GWF: STIMULATOR, ELECTRICAL, EVOKED RESPONSE

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: 2018-08-28
• Device Publish Date: 2016-04-07

On-Brand Devices [APS™]

• 00643169344983: HANDSWITCH 8253054 APS NERVE ELECTR ROHS
• 00643169309333: ELECTRODE 8228053 APS 3MM ROHS
• 00643169309326: ELECTRODE 8228052 APS 2MM ROHS