Autoscaler®

GUDID 00859191006021

25K Build In Ultrasonic Scaler 120 VAC

SOUTH EAST INSTRUMENTS LLC

Ultrasonic dental scaling/debridement system

• Primary Device ID: 00859191006021
• NIH Device Record Key: 45c78b81-78b5-43b4-a090-ceb96d8ba3dc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Autoscaler®
• Version Model Number: AW25BI
• Company DUNS: 080231739
• Company Name: SOUTH EAST INSTRUMENTS 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-648-9445
• Email: info@southeastinstruments.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00859191006021 [Primary]

FDA Product Code

• ELC: Scaler, Ultrasonic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-01

On-Brand Devices [Autoscaler®]

• 00859191006038: 30K Build In Ultrasonic Scaler 120 VAC
• 00859191006021: 25K Build In Ultrasonic Scaler 120 VAC
• 00859191006014: 30K Ultrasonic Scaler 120 VAC
• 00859191006007: 25K Ultrasonic Scaler 120 VAC