Stealth Midas™

GUDID 00643169595163

MOTOR EM200N STEALTH-MIDAS STYLUS

MEDTRONIC POWERED SURGICAL SOLUTIONS

Line-powered surgical power tool system motor Line-powered surgical power tool system motor Bone/joint surgical power tool motor, electric Bone/joint surgical power tool motor, electric Bone/joint surgical power tool motor, electric Bone/joint surgical power tool motor, electric Bone/joint surgical power tool motor, electric Bone/joint surgical power tool motor, electric Bone/joint surgical power tool motor, electric Bone/joint surgical power tool motor, electric Bone/joint surgical power tool motor, electric Bone/joint surgical power tool motor, electric Bone/joint surgical power tool motor, electric Bone/joint surgical power tool motor, electric Bone/joint surgical power tool motor, electric Bone/joint surgical power tool motor, electric Bone/joint surgical power tool motor, electric Bone/joint surgical power tool motor, electric Bone/joint surgical power tool motor, electric

• Primary Device ID: 00643169595163
• NIH Device Record Key: 3ebf05f9-f8fb-4cb7-a27f-5cda52c97fff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Stealth Midas™
• Version Model Number: EM200N
• Company DUNS: 098308849
• Company Name: MEDTRONIC POWERED SURGICAL SOLUTIONS
• 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
• 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	00643169595163 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160713

FDA Product Code

• OLO: Orthopedic stereotaxic instrument

Sterilization

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

[00643169595163]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00643169595163]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00643169595163]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00643169595163]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00643169595163]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00643169595163]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00643169595163]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00643169595163]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00643169595163]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00643169595163]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00643169595163]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00643169595163]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00643169595163]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00643169595163]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00643169595163]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00643169595163]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00643169595163]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00643169595163]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00643169595163]

Ethylene Oxide;Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-10

On-Brand Devices [Stealth Midas™]

• 00643169595187: INST CASE PA600N FOR STEALTH-MIDAS MOTOR
• 00643169595170: MOTOR PM700N STEALTH-MIDAS PNEUMATIC
• 00643169595163: MOTOR EM200N STEALTH-MIDAS STYLUS
• 00763000172848: MOTOR EM200N STEALTH-MIDAS STYLUS