O-arm
GUDID 00763000616564
O-ARM SYS BI70002000 O2 UE 120V B EN UEN
MEDTRONIC NAVIGATION, INC.
Portable general-purpose fluoroscopic x-ray system, digital Portable general-purpose fluoroscopic x-ray system, digital Portable general-purpose fluoroscopic x-ray system, digital Portable general-purpose fluoroscopic x-ray system, digital Portable general-purpose fluoroscopic x-ray system, digital Portable general-purpose fluoroscopic x-ray system, digital Portable general-purpose fluoroscopic x-ray system, digital Portable general-purpose fluoroscopic x-ray system, digital Portable general-purpose fluoroscopic x-ray system, digital Portable general-purpose fluoroscopic x-ray system, digital Portable general-purpose fluoroscopic x-ray system, digital| Primary Device ID | 00763000616564 |
| NIH Device Record Key | 1e374672-33b8-4a86-ba0a-bee6f486cdb3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | O-arm |
| Version Model Number | BI70002000 |
| Company DUNS | 803580559 |
| 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 | 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 | 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00763000616564 [Primary] |
FDA Product Code
| OWB | Interventional fluoroscopic x-ray system |
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 | 2022-05-09 |
| Device Publish Date | 2022-04-29 |
Devices Manufactured by MEDTRONIC NAVIGATION, INC.
| 00763000457365 - Medtronic Navigation | 2024-06-17 SFW KIT 9735917 S8 DBS 2ND LIC EU-E |
| 00763000457389 - Medtronic Navigation | 2024-06-17 SFW KIT 9735917 S8 DBS 2ND LIC EU-SC |
| 00763000457402 - Medtronic Navigation | 2024-06-17 SFW KIT 9735917 S8 DBS 2ND LIC EU-SE |
| 00763000457617 - Medtronic Navigation | 2024-06-17 SFW KIT 9735921 S8 DSC STEREOTX EU-SD |
| 00763000457822 - Medtronic Navigation | 2024-06-17 SW KIT 9735918 S8 STEREOTX 2ND LIC EU-SC |
| 00763000457846 - Medtronic Navigation | 2024-06-17 SW KIT 9735918 S8 STEREOTX 2ND LIC EU-SE |
| 00763000849320 - StealthStation Cranial | 2024-05-28 SWKT 9735586 STEALTH CRANIAL 3.1.5 |
| 00763000863302 - O-arm O2 | 2024-05-28 O-ARM SYS BI70002000 O2 UE 120V B EN UEN |
Trademark Results [O-arm]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 O-ARM 78111049 3101416 Live/Registered |
MEDTRONIC NAVIGATION, INC. 2002-02-26 |
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