Ziehm

GUDID 00763000114596

KIT 9736093 RFD TRACKER INTEGRATION

MEDTRONIC NAVIGATION, INC.

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.

• 00763000927127 - Medtronic: 2024-12-13 INST SET 9735283 SOLERA 5.5/6.0 DRVR
• 00763000927189 - Medtronic: 2024-12-13 INST SET 9734495 REFERENCING STD
• 00763000927233 - Medtronic: 2024-12-13 INST SET 9734494 TACTILE PROBES
• 00763000922412 - Medtronic: 2024-11-25 INST SET 9733935 CRANIAL PASSIVE
• 00763000927035 - NavLock™: 2024-11-25 INST SET 9734833 UNIVERSAL NAVLOCK
• 00763000927042 - NavLock™: 2024-11-25 INST SET 9734834 CAPSTONE TRIALS
• 00763000927059 - NavLock™: 2024-11-25 INST SET 9734835 CLYDESDALE TRIALS
• 00763000927066 - Medtronic: 2024-11-25 INST SET 9734836 TLIF/DLIF INSERTER