Stealth Autoguide™ System
GUDID 00763000536367
DRILL GUIDE 28322 BURR HOLE AUTOGUIDE
MEDTRONIC NAVIGATION, INC.
Surgical drill guide, reusable| Primary Device ID | 00763000536367 |
| NIH Device Record Key | 376bb889-7fcc-4322-ba24-255cb963f74a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Stealth Autoguide™ System |
| Version Model Number | 28322 |
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00763000536367 [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 |
[00763000536367]
Moist Heat or Steam Sterilization
[00763000536367]
Moist Heat or Steam Sterilization
[00763000536367]
Moist Heat or Steam Sterilization
[00763000536367]
Moist Heat or Steam Sterilization
[00763000536367]
Moist Heat or Steam Sterilization
[00763000536367]
Moist Heat or Steam Sterilization
[00763000536367]
Moist Heat or Steam Sterilization
[00763000536367]
Moist Heat or Steam Sterilization
[00763000536367]
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]
| 00763000215828 | DRILL GUIDE 28326 STAB INCISION AG |
| 00763000215811 | VISUALASE DRILL GUIDE 28324 AUTOGUIDE |
| 00763000215804 | DRILL GUIDE 28322 BURR HOLE AUTOGUIDE |
| 00763000334086 | SET 9736191 GUIDING JOINTS |
| 00763000331788 | GUIDING INSERTS 30463 STEALTH AUTOGUIDE |
| 00763000318321 | SET 9736189 VISUALSE INST AUTOGUIDE |
| 00763000318314 | SET 9736188 BASIC INSTRUMENT AUTOGUIDE |
| 00763000293659 | SYSTEM 29631 STEALTH AUTOGUIDE |
| 00763000293642 | SRB 29193 STEALTH AUTOGUIDE |
| 00763000293635 | CONTROL UNIT 28080 STEALTH AUTOGUIDE |
| 00763000293628 | TARGETING UNIT 25650 STEALTH AUTOGUIDE |
| 00763000240219 | ADAPTER 29439 AUTOGUIDE HEAD CLAMP |
| 00763000240202 | RATCHETING ARM 29480 STEALTH AUTOGUIDE |
| 00763000216696 | OBTURATOR 28340 STAB INCISION AUTOGUIDE |
| 00763000216689 | VISUALASE OBTURATOR 28338 AUTOGUIDE |
| 00763000215873 | REDUCING TUBE 2.2MM 28336 SEEG AUTOGUIDE |
| 00763000215866 | REDUCING TUBE 2.2MM 28334 BURR HOLE AG |
| 00763000215859 | VISUALASE REDUCING TUBE 28332 1.7MM AG |
| 00763000215842 | REDUCING TUBE 2.2MM 28330 STAB BIOPSY AG |
| 00763000215835 | REDUCING TUBE 4.0MM 28328 SEEG AUTOGUIDE |
| 00763000205898 | GUIDING INSERT 28249 LOWER AUTOGUIDE |
| 00763000205881 | TAPPING TUBE 31527 STEALTH AUTOGUIDE |
| 00763000205874 | TRACKER 28248 STEALTH AUTOGUIDE |
| 00763000205867 | GUIDING INSERT 27586 UPPER AUTOGUIDE |
| 00763000205850 | GUIDING JOINT 27584 STEALTH AUTOGUIDE |
| 00763000205843 | VISUALASE HEIGHT GUIDE 27565 AUTOGUIDE |
| 00763000205836 | STAB INCISION HGT GUIDE 27563 AUTOGUIDE |
| 00763000536343 | TRACKER 28248 STEALTH AUTOGUIDE |
| 00763000571849 | SET 9736188 BASIC INST AUTOGUIDE |
| 00763000571856 | SET 9736189 VISUALASE INST AUTOGUIDE |
| 00763000571832 | SET 9736188 BASIC INST AUTOGUIDE |
| 00763000536459 | VISUALASE REDUCING TUBE 28332 1.7MM AG |
| 00763000536442 | VISUALASE DRILL GUIDE 28324 AUTOGUIDE |
| 00763000536435 | VISUALASE OBTURATOR 28338 AUTOGUIDE |
| 00763000536428 | VISUALASE HEIGHT GUIDE 27565 AUTOGUIDE |
| 00763000536411 | OBTURATOR 28340 STAB INCISION AUTOGUIDE |
| 00763000536404 | REDUCING TUBE 2.2MM 28334 BURR HOLE AG |
| 00763000536398 | REDUCING TUBE 4.0MM 28328 SEEG AUTOGUIDE |
| 00763000536374 | REDUCING TUBE 2.2MM 28330 STAB BIOPSY AG |
| 00763000536367 | DRILL GUIDE 28322 BURR HOLE AUTOGUIDE |
| 00763000536350 | DRILL GUIDE 28326 STAB INCISION AG |
| 00763000536336 | TAPPING TUBE 31527 STEALTH AUTOGUIDE |
| 00763000536312 | SET 9736191 GUIDING JOINT AUTOGUIDE |
| 00763000536305 | GUIDING INSERTS 30463 AUTOGUIDE |
| 00763000536299 | ADAPTER 29439 AUTOGUIDE HEAD CLAMP |
| 00763000536282 | POSITIONING ARM 29480 AUTOGUIDE |
| 00763000536275 | SRB 29193 STEALTH AUTOGUIDE |
| 00763000536251 | CONTROL UNIT 28080 STEALTH AUTOGUIDE |
| 00763000536244 | TARGETING UNIT 25650 STEALTH AUTOGUIDE |
| 00763000362416 | SYSTEM 29631 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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