Stealth Autoguide
GUDID 00763000630072
SET 9736464 BASIC INST AUTOGUIDE II
MEDTRONIC NAVIGATION, INC.
Multi-purpose stereotactic surgery system| Primary Device ID | 00763000630072 |
| NIH Device Record Key | 4e8f76f6-1900-4b51-90c7-7af27ff334dd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Stealth Autoguide |
| Version Model Number | 9736464 |
| 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
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00763000630072 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K191597
FDA Product Code
| HAW | Neurological stereotaxic Instrument |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00763000630072]
Moist Heat or Steam Sterilization
[00763000630072]
Moist Heat or Steam Sterilization
[00763000630072]
Moist Heat or Steam Sterilization
[00763000630072]
Moist Heat or Steam Sterilization
[00763000630072]
Moist Heat or Steam Sterilization
[00763000630072]
Moist Heat or Steam Sterilization
[00763000630072]
Moist Heat or Steam Sterilization
[00763000630072]
Moist Heat or Steam Sterilization
[00763000630072]
Moist Heat or Steam Sterilization
[00763000630072]
Moist Heat or Steam Sterilization
[00763000630072]
Moist Heat or Steam Sterilization
[00763000630072]
Moist Heat or Steam Sterilization
[00763000630072]
Moist Heat or Steam Sterilization
[00763000630072]
Moist Heat or Steam Sterilization
[00763000630072]
Moist Heat or Steam Sterilization
[00763000630072]
Moist Heat or Steam Sterilization
[00763000630072]
Moist Heat or Steam Sterilization
[00763000630072]
Moist Heat or Steam Sterilization
[00763000630072]
Moist Heat or Steam Sterilization
[00763000630072]
Moist Heat or Steam Sterilization
[00763000630072]
Moist Heat or Steam Sterilization
[00763000630072]
Moist Heat or Steam Sterilization
[00763000630072]
Moist Heat or Steam Sterilization
[00763000630072]
Moist Heat or Steam Sterilization
[00763000630072]
Moist Heat or Steam Sterilization
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 [Stealth Autoguide]
| 00763000630072 | SET 9736464 BASIC INST AUTOGUIDE II |
| 00763000536381 | REDUCING TUBE 2.4MM 28336 SEEG AUTOGUIDE |
| 00763000705008 | SYSTEM 29631 STEALTH AUTOGUIDE ENG ONLY |
Trademark Results [Stealth Autoguide]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 STEALTH AUTOGUIDE 87537333 not registered Live/Pending |
Medtronic Navigation, Inc. 2017-07-21 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.