Integrated Power Console

GUDID 00643169931398

FOOT SWITCH 1898430 ROHS

MEDTRONIC XOMED, INC.

Foot-switch, electrical Foot-switch, electrical

• Primary Device ID: 00643169931398
• NIH Device Record Key: df9b8155-19af-4935-a1d5-d19d44a9b3a1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Integrated Power Console
• Version Model Number: 1898430
• 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: false
• Serial Number: true
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169931398 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081277

FDA Product Code

• ERL: DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-10-16

On-Brand Devices [Integrated Power Console]

• 00643169931411: CONSOLE 1898001RF IPC REFURB
• 00643169931404: CONSOLE 1898001LO LOANER ENT IPC
• 00643169931398: FOOT SWITCH 1898430 ROHS