MIDAS REX STEALTH MIDAS

GUDID 00763000430900

MOTOR EM200N STEALTH-MIDAS STYLUS

MEDTRONIC POWERED SURGICAL SOLUTIONS

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: 00763000430900
• NIH Device Record Key: 7158647a-eb09-4d7f-8488-dc0c7f5a3fd0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MIDAS REX 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000430900 [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

[00763000430900]

Ethylene Oxide

[00763000430900]

Ethylene Oxide

[00763000430900]

Ethylene Oxide

[00763000430900]

Ethylene Oxide

[00763000430900]

Ethylene Oxide

[00763000430900]

Ethylene Oxide

[00763000430900]

Ethylene Oxide

[00763000430900]

Ethylene Oxide

[00763000430900]

Ethylene Oxide

[00763000430900]

Ethylene Oxide

[00763000430900]

Ethylene Oxide

[00763000430900]

Ethylene Oxide

[00763000430900]

Ethylene Oxide

[00763000430900]

Ethylene Oxide

[00763000430900]

Ethylene Oxide

[00763000430900]

Ethylene Oxide

[00763000430900]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-11-15
• Device Publish Date: 2022-01-06

Devices Manufactured by MEDTRONIC POWERED SURGICAL SOLUTIONS

• 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
• 00763000732974 - MR8: 2024-01-26 TOOL MR8-SD12BA40D MR8 12CM SD B D 4MM
• 00763000732981 - MR8: 2024-01-26 TOOL MR8-SD12BA30DC MR8 12CM SD B DC3MM
• 00763000732998 - MR8: 2024-01-26 TOOL MR8-SD12BA40DC MR8 12CM SD B DC4MM
• 00763000737276 - MR8: 2024-01-26 TOOL MR8-ND13BA40D MR8 13CM ND B D 4MM
• 00763000651152 - MR8: 2023-12-11 TOOL MR8-15MH30SH MR8 15CM 3MM MATCH SH
• 00763000714635 - MR8: 2023-12-11 TOOL MR8-10MH30SH 10CM MATCH 3MM SHORT