Stealth Autoguide™ System

GUDID 00763000536268

PNU 28635 STEALTH AUTOGUIDE

MEDTRONIC SOFAMOR DANEK, INC.

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• 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

• 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
• 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	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