Hu-Friedy

Basic Information

• Brand Name: Hu-Friedy
• Primary DI: 10889950075835
• Version / Model: UM3-25EU
• Catalog Number: UM3-25EU
• Company Name: HU-FRIEDY MFG. CO., LLC
• Labeler DUNS: 005085972
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-21
• Public Version: 4
• Public Version Date: 2022-01-20
• Public Version Status: Update
• Public Device Record Key: 3847d9c0-7c8c-4f82-bdf5-104745b92968
• Distribution End Date: 2022-01-19

Device Description

Magnetostrict.Generator 3000-25k,230V EU

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ELC	Scaler, ultrasonic	Dental	872.4850	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44906	Ultrasonic dental scaling/debridement system generator	A mains electricity (AC-powered) unit that functions as part of an ultrasonic dental scaling/debridement system, intended to generate, and enable control of, ultrasonic oscillations to: 1) mechanically fragment and dislodge gross debris in the dental pulp canal during an endodontic procedure; and/or 2) remove accretions from tooth surfaces during dental cleaning/periodontal therapy. It connects to the system handpiece, and may connect to a suitable water supply, or it may contain the water or rinsing solution (e.g., chlorhexidine) source.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10889950075835	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K100401	000

Storage Conditions

• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 50 – 106 KiloPascal
• Type: Storage Environment Humidity
• Temperature Range: 10 – 85 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -10 – 60 Degrees Celsius