Surgi-Max Drill System

GUDID 00846338002664

ELLIQUENCE, LLC

Surgical power tool system control unit, line-powered

• Primary Device ID: 00846338002664
• NIH Device Record Key: 8cf37f06-1168-42cf-9364-96e42b0fd237
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Surgi-Max Drill System
• Version Model Number: 16-0002
• Company DUNS: 019872358
• Company Name: ELLIQUENCE, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00846338002664 [Primary]

FDA Product Code

• GEY: Motor, Surgical Instrument, Ac-Powered

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-01-17
• Device Publish Date: 2025-01-09

On-Brand Devices [Surgi-Max Drill System]

• 00846338002671: 16-0003
• 00846338002664: 16-0002