Midas-Rex, MR8

GUDID 00763000335885

ATT MR8-AS23N-R MR8 23CM STR NAV3.2MMRFB

MEDTRONIC POWERED SURGICAL SOLUTIONS

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• Primary Device ID: 00763000335885
• NIH Device Record Key: ea01d958-1aed-4ffb-b167-bd46b70b1e46
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Midas-Rex, MR8
• Version Model Number: MR8-AS23N-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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000335885 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202552

FDA Product Code

• OLO: Orthopedic stereotaxic instrument

Sterilization

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

[00763000335885]

Moist Heat or Steam Sterilization

[00763000335885]

Moist Heat or Steam Sterilization

[00763000335885]

Moist Heat or Steam Sterilization

[00763000335885]

Moist Heat or Steam Sterilization

[00763000335885]

Moist Heat or Steam Sterilization

[00763000335885]

Moist Heat or Steam Sterilization

[00763000335885]

Moist Heat or Steam Sterilization

[00763000335885]

Moist Heat or Steam Sterilization

[00763000335885]

Moist Heat or Steam Sterilization

[00763000335885]

Moist Heat or Steam Sterilization

[00763000335885]

Moist Heat or Steam Sterilization

[00763000335885]

Moist Heat or Steam Sterilization

[00763000335885]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-04-26
• Device Publish Date: 2021-04-16

On-Brand Devices [Midas-Rex, MR8]

• 00763000335892: ATT MR8-AS31N-R MR8 31CM STR NAV3.2MMRFB
• 00763000335885: ATT MR8-AS23N-R MR8 23CM STR NAV3.2MMRFB
• 00763000335878: ATT MR8-AS31-R MR8 31CM STRT 3.2MM REFRB
• 00763000335861: ATT MR8-AS23-R MR8 23CM STRT 3.2MM REFRB