MR8 Attachments

GUDID 00763000732882

ATT MR8-AS14P-R MR8 14CM PRECSN GRFT RFB

MEDTRONIC POWERED SURGICAL SOLUTIONS

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• Primary Device ID: 00763000732882
• NIH Device Record Key: 65bae7d8-4595-4bb5-a97b-343641d3d615
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MR8 Attachments
• Version Model Number: MR8-AS14P-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: false
• 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	00763000732882 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183515

FDA Product Code

• ERL: DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE

Sterilization

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

[00763000732882]

Ethylene Oxide

[00763000732882]

Ethylene Oxide

[00763000732882]

Ethylene Oxide

[00763000732882]

Ethylene Oxide

[00763000732882]

Ethylene Oxide

[00763000732882]

Ethylene Oxide

[00763000732882]

Ethylene Oxide

[00763000732882]

Ethylene Oxide

[00763000732882]

Ethylene Oxide

[00763000732882]

Ethylene Oxide

[00763000732882]

Ethylene Oxide

[00763000732882]

Ethylene Oxide

[00763000732882]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-12-05
• Device Publish Date: 2023-11-27

On-Brand Devices [MR8 Attachments]

• 00763000732875: ATT MR8 MR8-AS14P 14CM PRECISION GRAFT
• 00763000732882: ATT MR8-AS14P-R MR8 14CM PRECSN GRFT RFB