Stealth Autoguide™ System
GUDID 00763000536268
PNU 28635 STEALTH AUTOGUIDE
MEDTRONIC SOFAMOR DANEK, INC.
Multi-purpose stereotactic surgery system| Primary Device ID | 00763000536268 |
| NIH Device Record Key | 73bac630-6af4-4041-8069-c16d5593466b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Stealth Autoguide™ System |
| Version Model Number | 28635 |
| Company DUNS | 830350380 |
| Company Name | MEDTRONIC SOFAMOR DANEK, 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 | 00763000536268 [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 |
[00763000536268]
Moist Heat or Steam Sterilization
[00763000536268]
Moist Heat or Steam Sterilization
[00763000536268]
Moist Heat or Steam Sterilization
[00763000536268]
Moist Heat or Steam Sterilization
[00763000536268]
Moist Heat or Steam Sterilization
[00763000536268]
Moist Heat or Steam Sterilization
[00763000536268]
Moist Heat or Steam Sterilization
[00763000536268]
Moist Heat or Steam Sterilization
[00763000536268]
Moist Heat or Steam Sterilization
[00763000536268]
Moist Heat or Steam Sterilization
[00763000536268]
Moist Heat or Steam Sterilization
[00763000536268]
Moist Heat or Steam Sterilization
[00763000536268]
Moist Heat or Steam Sterilization
[00763000536268]
Moist Heat or Steam Sterilization
[00763000536268]
Moist Heat or Steam Sterilization
[00763000536268]
Moist Heat or Steam Sterilization
[00763000536268]
Moist Heat or Steam Sterilization
[00763000536268]
Moist Heat or Steam Sterilization
[00763000536268]
Moist Heat or Steam Sterilization
[00763000536268]
Moist Heat or Steam Sterilization
[00763000536268]
Moist Heat or Steam Sterilization
[00763000536268]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-08-15 |
| Device Publish Date | 2022-08-05 |
On-Brand Devices [Stealth Autoguide™ System]
| 00763000293666 | PNU 28635 STEALTH AUTOGUIDE |
| 00763000536268 | PNU 28635 STEALTH AUTOGUIDE |
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 |
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