StealthConnect
GUDID 00643169705432
SFTW KIT 9735696 STEALTHCONNECT SYS
MEDTRONIC NAVIGATION, INC.
Stereotactic system application software| Primary Device ID | 00643169705432 |
| NIH Device Record Key | 2da2a3c3-6928-495d-b295-fbf17e15ed28 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | StealthConnect |
| Version Model Number | 9735696 |
| 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 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00643169705432 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K162655
FDA Product Code
| HAW | Neurological 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 | 2 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2018-04-15 |
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 |
Trademark Results [StealthConnect]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 STEALTHCONNECT 87144252 not registered Live/Pending |
Medtronic Navigation, Inc. 2016-08-19 |
 STEALTHCONNECT 85848624 not registered Dead/Abandoned |
Medtronic Navigation, Inc. 2013-02-13 |
 STEALTHCONNECT 75499748 not registered Dead/Abandoned |
OneNetwork, Inc 1998-06-09 |
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