Stealth Autoguide™ System

GUDID 00763000205843

VISUALASE HEIGHT GUIDE 27565 AUTOGUIDE

MEDTRONIC NAVIGATION, INC.

Multi-purpose stereotactic surgery system

• Primary Device ID: 00763000205843
• NIH Device Record Key: fc871bcf-9478-448a-ae9a-9419d8725b61
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Stealth Autoguide™ System
• Version Model Number: 27565
• 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
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000205843 [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

[00763000205843]

Moist Heat or Steam Sterilization

[00763000205843]

Moist Heat or Steam Sterilization

[00763000205843]

Moist Heat or Steam Sterilization

[00763000205843]

Moist Heat or Steam Sterilization

[00763000205843]

Moist Heat or Steam Sterilization

[00763000205843]

Moist Heat or Steam Sterilization

[00763000205843]

Moist Heat or Steam Sterilization

[00763000205843]

Moist Heat or Steam Sterilization

[00763000205843]

Moist Heat or Steam Sterilization

[00763000205843]

Moist Heat or Steam Sterilization

[00763000205843]

Moist Heat or Steam Sterilization

[00763000205843]

Moist Heat or Steam Sterilization

[00763000205843]

Moist Heat or Steam Sterilization

[00763000205843]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-01-06
• Device Publish Date: 2019-12-27

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