Stealth Midas™

GUDID 00643169595170

MOTOR PM700N STEALTH-MIDAS PNEUMATIC

MEDTRONIC POWERED SURGICAL SOLUTIONS

Surgical power tool system handpiece, rotary, pneumatic Surgical power tool system handpiece, rotary, pneumatic Surgical power tool system control unit, pneumatic Surgical power tool system control unit, pneumatic Surgical power tool system control unit, pneumatic Surgical power tool system control unit, pneumatic Surgical power tool system control unit, pneumatic Surgical power tool system control unit, pneumatic Surgical power tool system control unit, pneumatic Surgical power tool system control unit, pneumatic Surgical power tool system control unit, pneumatic Surgical power tool system control unit, pneumatic Surgical power tool system control unit, pneumatic Surgical power tool system control unit, pneumatic Surgical power tool system control unit, pneumatic Surgical power tool system control unit, pneumatic Surgical power tool system control unit, pneumatic Surgical power tool system control unit, pneumatic Surgical power tool system control unit, pneumatic

• Primary Device ID: 00643169595170
• NIH Device Record Key: 5d4e0104-ff95-4bed-975d-090c02fd6809
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Stealth Midas™
• Version Model Number: PM700N
• 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	00643169595170 [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

[00643169595170]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00643169595170]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00643169595170]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00643169595170]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00643169595170]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00643169595170]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00643169595170]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00643169595170]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00643169595170]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00643169595170]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00643169595170]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00643169595170]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00643169595170]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00643169595170]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00643169595170]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00643169595170]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00643169595170]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00643169595170]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00643169595170]

Ethylene Oxide;Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-11-22
• 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