Powerease®

GUDID 00763000033927

CABLE 2344000 POWEREASE NIM

MEDTRONIC SOFAMOR DANEK, INC.

Multi-purpose surgical power tool system, line-powered Bone/joint surgical power tool motorized handpiece/set, electric, reusable Bone/joint surgical power tool motorized handpiece/set, electric, reusable Bone/joint surgical power tool motorized handpiece/set, electric, reusable Bone/joint surgical power tool motorized handpiece/set, electric, reusable Bone/joint surgical power tool motorized handpiece/set, electric, reusable Bone/joint surgical power tool motorized handpiece/set, electric, reusable Bone/joint surgical power tool motorized handpiece/set, electric, reusable Bone/joint surgical power tool motorized handpiece/set, electric, reusable Bone/joint surgical power tool motorized handpiece/set, electric, reusable Bone/joint surgical power tool motorized handpiece/set, electric, reusable Bone/joint surgical power tool motorized handpiece/set, electric, reusable Bone/joint surgical power tool motorized handpiece/set, electric, reusable Bone/joint surgical power tool motorized handpiece/set, electric, reusable Bone/joint surgical power tool motorized handpiece/set, electric, reusable Bone/joint surgical power tool motorized handpiece/set, electric, reusable Bone/joint surgical power tool motorized handpiece/set, electric, reusable Bone/joint surgical power tool motorized handpiece/set, electric, reusable

• Primary Device ID: 00763000033927
• NIH Device Record Key: 467ab9bf-612e-4929-9096-ab0362880170
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Powerease®
• Version Model Number: 2344000
• Company DUNS: 830350380
• Company Name: MEDTRONIC SOFAMOR DANEK, 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000033927 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111520

FDA Product Code

• HWE: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-09-16
• Device Publish Date: 2019-09-08

On-Brand Devices [Powerease®]

• 00643169882812: DRIVER 2300000LO POWEREASE LOANER
• 00763000033927: CABLE 2344000 POWEREASE NIM