Medtronic Navigation

GUDID 00763000457358

SFW KIT 9735917 S8 DBS 2ND LIC

MEDTRONIC NAVIGATION, INC.

Neurological stereotactic surgery system

• Primary Device ID: 00763000457358
• NIH Device Record Key: 985c8f68-4362-4c11-9b07-ffa32263acf4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Medtronic Navigation
• Version Model Number: 9735917
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000457358 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203639

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: 2022-05-16
• Device Publish Date: 2022-05-08

On-Brand Devices [Medtronic Navigation]

• 00763000456986: SFW 9735762 APP STEALTH S8 APPLICATION
• 00763000457068: SW KT 9735737 STEALTH S8 1.3.2 CRANIAL
• 00763000475833: SFW KIT 9735738 STEALTH S8 CRN DBS
• 00763000475895: SFW KIT 9735738 STEALTH S8 CRN DBS EU-SW
• 00763000475888: SFW KIT 9735738 STEALTH S8 CRN DBS EU-SE
• 00763000475871: SFW KIT 9735738 STEALTH S8 CRN DBS EU-SD
• 00763000475864: SFW KIT 9735738 STEALTH S8 CRN DBS EU-SC
• 00763000475857: SFW KIT 9735738 STEALTH S8 CRN DBS EU-NW
• 00763000475840: SFW KIT 9735738 STEALTH S8 CRN DBS EU-E
• 00763000457716: SFW KIT 9736226 STEALTH FLEX ENT
• 00763000457709: SW KT 9736025 S8 1.3.2 MCRSCP AUTOPOS
• 00763000457693: SW KT 9736025 S8 1.3.2 MCRSCP AUTO EU-SW
• 00763000457686: SW KT 9736025 S8 1.3.2 MCRSCP AUTO EU-SE
• 00763000457679: SW KT 9736025 S8 1.3.2 MCRSCP AUTO EU-SD
• 00763000457662: SW KT 9736025 S8 1.3.2 MCRSCP AUTO EU-SC
• 00763000457655: SW KT 9736025 S8 1.3.2 MCRSCP AUTO EU-NW
• 00763000457648: SW KT 9736025 S8 1.3.2 MCRSCP AUTO EU-E
• 00763000457426: SFW KIT 9735918 S8 STEREOTX 2ND LIC
• 00763000457341: SW KT 9735916 S8 1.3.2 CRANIAL PLAN STAT
• 00763000457334: SW KT 9735916 S8 1.3.2 CRANIAL PS EU-SW
• 00763000457327: SW KT 9735916 S8 1.3.2 CRANIAL PS EU-SE
• 00763000457310: SW KT 9735916 S8 1.3.2 CRANIAL PS EU-SD
• 00763000457303: SW KT 9735916 S8 1.3.2 CRANIAL PS EU-SC
• 00763000457297: SW KT 9735916 S8 1.3.2 CRANIAL PS EU-NW
• 00763000457280: SW KT 9735916 S8 1.3.2 CRANIAL PS EU-E
• 00763000457204: SFW KIT 9735740 STEALTH S8 SPINE
• 00763000457198: SFW KIT 9735739 STLTH S8 STEREOTX EU-SW
• 00763000457181: SFW KIT 9735739 STLTH S8 STEREOTX EU-SE
• 00763000457174: SFW KIT 9735739 STLTH S8 STEREOTX EU-SD
• 00763000457167: SFW KIT 9735739 STLTH S8 STEREOTX EU-SC
• 00763000457150: SFW KIT 9735739 STLTH S8 STEREOTX EU-NW
• 00763000457143: SFW KIT 9735739 STLTH S8 STEREOTX EU-E
• 00763000457136: SFW KIT 9735739 STEALTH S8 STEREOTX
• 00763000456993: SFW KIT 9735736 STEALTH S8 ENT
• 00763000456887: SFW KIT 9735930 STEALTHVIZ S8 INT
• 00763000456870: SFW KIT 9735929 STEALTHVIZ S8 DEMO EU-SW
• 00763000456863: SFW KIT 9735929 STEALTHVIZ S8 DEMO EU-SE
• 00763000456856: SFW KIT 9735929 STEALTHVIZ S8 DEMO EU-SD
• 00763000456849: SFW KIT 9735929 STEALTHVIZ S8 DEMO EU-NW
• 00763000456832: SFW KIT 9735929 STEALTHVIZ S8 DEMO EU-E
• 00763000456825: SFW KIT 9735929 STEALTHVIZ S8 DEMO
• 00763000456818: SW KT 9735900 STEALTHVIZ S8 60DAY EU-SW
• 00763000456801: SW KT 9735900 STEALTHVIZ S8 60DAY EU-SE
• 00763000456795: SW KT 9735900 STEALTHVIZ S8 60DAY EU-SD
• 00763000456788: SW KT 9735900 STEALTHVIZ S8 60DAY EU-NW
• 00763000456771: SW KT 9735900 STEALTHVIZ S8 60DAY EU-E
• 00763000456764: SFW KIT 9735900 STEALTHVIZ S8 60DAY
• 00763000456740: SW KT 9735899 STEALTHVIZ S8 MULTI EU-SE
• 00763000456733: SW KT 9735899 STEALTHVIZ S8 MULTI EU-SD
• 00763000456726: SW KT 9735899 STEALTHVIZ S8 MULTI EU-NW