Medtronic Navigation
GUDID 00763000457204
SFW KIT 9735740 STEALTH S8 SPINE
MEDTRONIC NAVIGATION, INC.
Orthopaedic stereotactic surgery system| Primary Device ID | 00763000457204 |
| NIH Device Record Key | 580c045f-f379-4983-9959-d6075322d176 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Medtronic Navigation |
| Version Model Number | 9735740 |
| 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 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00763000457204 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K201189
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 | 2021-04-12 |
| Device Publish Date | 2021-04-04 |
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 |
Trademark Results [Medtronic Navigation]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MEDTRONIC NAVIGATION 78532812 3276443 Dead/Cancelled |
Medtronic, Inc. 2004-12-15 |
 MEDTRONIC NAVIGATION 78532795 not registered Dead/Abandoned |
Medtronic, Inc. 2004-12-15 |
 MEDTRONIC NAVIGATION 78532774 3265822 Dead/Cancelled |
Medtronic, Inc. 2004-12-15 |
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