Ziehm

GUDID 00763000114596

KIT 9736093 RFD TRACKER INTEGRATION

MEDTRONIC NAVIGATION, INC.

Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system

• Primary Device ID: 00763000114596
• NIH Device Record Key: 8194e475-d8a5-4925-ae05-d13a4aa56a2b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ziehm
• Version Model Number: 9736093
• Company DUNS: 835233107
• Company Name: MEDTRONIC NAVIGATION, INC.
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000114596 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180816

FDA Product Code

• OLO: Orthopedic stereotaxic instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-10-18
• Device Publish Date: 2018-09-17

Devices Manufactured by MEDTRONIC NAVIGATION, INC.

• 20643169868131 - O-ARM®: 2024-04-15 MOUSE 9732721 STERILE O-ARM 10
• 00763000768744 - StealthStation S8: 2023-12-05 SW KIT 9735736 S8 2.1 ENT
• 00763000768867 - StealthStation S8: 2023-12-05 SW KIT 9735740 S8 2.1 SPINE
• 00763000768980 - StealthStation S8: 2023-12-05 SW KIT 9735919 S8 2.1 SPINE PLAN STATION
• 00763000769017 - StealthStation S8: 2023-12-05 SW KIT 9735920 S8 2.1 ENT PLAN STATION
• 00763000769123 - StealthStation S8: 2023-12-05 SW KIT 9736226 FLEX 2.1 ENT
• 00763000769192 - StealthStation S8: 2023-12-05 SW KIT 9736350 S8 2.1 AIR
• 00763000769208 - StealthStation S8: 2023-12-05 SFW KIT 9736186 STEALTH-MIDAS MR8