DYNAMIS™ Navigation System SI0222

GUDID 00810152100882

5.0mm NAVIGATION TAP

PROMETHEAN RESTORATIVE LLC

Bone tap, reusable

• Primary Device ID: 00810152100882
• NIH Device Record Key: 45501c7c-27fe-439e-8a78-633e7d0dc3e3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DYNAMIS™ Navigation System
• Version Model Number: SI0222
• Catalog Number: SI0222
• Company DUNS: 124592779
• Company Name: PROMETHEAN RESTORATIVE LLC
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810152100882 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K252962

FDA Product Code

• OLO: Orthopedic Stereotaxic Instrument

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00810152100882]

Moist Heat or Steam Sterilization

[00810152100882]

Moist Heat or Steam Sterilization

[00810152100882]

Moist Heat or Steam Sterilization

[00810152100882]

Moist Heat or Steam Sterilization

[00810152100882]

Moist Heat or Steam Sterilization

[00810152100882]

Moist Heat or Steam Sterilization

[00810152100882]

Moist Heat or Steam Sterilization

[00810152100882]

Moist Heat or Steam Sterilization

[00810152100882]

Moist Heat or Steam Sterilization

[00810152100882]

Moist Heat or Steam Sterilization

[00810152100882]

Moist Heat or Steam Sterilization

[00810152100882]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-01-28
• Device Publish Date: 2026-01-20

On-Brand Devices [DYNAMIS™ Navigation System]

• 00810152103210: NAVIGATION PROTECTOR
• 00810152103197: SHORT NAVIGATED LOCKING DRIVER
• 00810152100936: NAVIGATION TRAY LID
• 00810152100929: NAVIGATION TRAY BASE
• 00810152100912: 8.0mm NAVIGATION TAP
• 00810152100905: 7.0mm NAVIGATION TAP
• 00810152100899: 6.0mm NAVIGATION TAP
• 00810152100882: 5.0mm NAVIGATION TAP
• 00810152100875: NAVIGATED TAPERED DRIVER
• 00810152100752: NAVIGATED LOCKING DRIVER
• 00810152100738: 13.0mm NAVIGATION TAP
• 00810152100721: 12.0mm NAVIGATION TAP
• 00810152100684: 11.0mm NAVIGATION TAP
• 00810152100677: 10.0mm NAVIGATION TAP
• 00810152100653: 9.0mm NAVIGATION TAP
• 00810152100646: NAVIGATION GUIDE PIN
• 00810152100516: NAVIGATED AWL