Stealth Midas

GUDID 00643169595194

MOTOR EM200N-R STLTH-MIDAS STYLS REFURB

MEDTRONIC POWERED SURGICAL SOLUTIONS

Line-powered surgical power tool system motor

• Primary Device ID: 00643169595194
• NIH Device Record Key: 45ef2d74-d1b9-4175-9e08-b02aa3733941
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Stealth Midas
• Version Model Number: EM200N-R
• 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	00643169595194 [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

[00643169595194]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00643169595194]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00643169595194]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00643169595194]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00643169595194]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00643169595194]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00643169595194]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00643169595194]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00643169595194]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00643169595194]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00643169595194]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00643169595194]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00643169595194]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00643169595194]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00643169595194]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00643169595194]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00643169595194]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00643169595194]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00643169595194]

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: 2017-04-22

Devices Manufactured by MEDTRONIC POWERED SURGICAL SOLUTIONS

• 00763000930837 - MIDAS REX MR8: 2024-10-11 TOOL MR8-9MH30P260 9CM MATCH 3MM P260MM
• 00763000714482 - MR8: 2024-08-27 TOOL MR8-10MH17L MR8 10CM MATCH 1.7MM L
• 00763000714536 - MR8: 2024-08-27 TOOL MR8-10BA80DC MR8 10CM BALL 8MM DC
• 00763000753382 - ENT MR8: 2024-06-17 UR 1847B20SCT ENTMR8 CUT 2MM STD
• 00763000753412 - ENT MR8: 2024-06-17 UR 1847B20SDM ENTMR8 DMD MED 2MM STD
• 00763000714550 - MR8 Tools: 2024-05-06 TOOL MR8-14TD3030 MR8 TWIST DRL 3MMX30MM
• 00763000732943 - MR8: 2024-01-26 TOOL MR8-ND13BA30D MR8 13CM ND B D 3MM
• 00763000732967 - MR8: 2024-01-26 TOOL MR8-SD12BA30D MR8 12CM SD B D 3MM