Powerease®

GUDID 00643169882812

DRIVER 2300000LO POWEREASE LOANER

MEDTRONIC SOFAMOR DANEK, INC.

Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00643169882812
• NIH Device Record Key: b50fa0b8-c153-40bd-b7c8-7417f2592b0b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Powerease®
• Version Model Number: 2300000LO
• 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: 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: 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

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
• 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	00643169882812 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111520

FDA Product Code

• HBE: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Sterilization

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

[00643169882812]

Moist Heat or Steam Sterilization

[00643169882812]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-07-12
• Device Publish Date: 2018-06-11

On-Brand Devices [Powerease®]

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