MIDWEST® RDH®

Basic Information

• Brand Name: MIDWEST® RDH®
• Primary DI: D0037400001
• Version / Model: 740000
• Catalog Number: 740000
• Company Name: Dentsply Professional
• Labeler DUNS: 144140845
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-11-27
• Public Version: 1
• Public Version Date: 2022-12-05
• Public Version Status: New
• Public Device Record Key: 455ef6f8-e346-4a25-8ba6-d51f6c35c1f3

Device Description

MIDWEST® RDH® Hygienist Handpiece for Disposable Angles- Single Pack

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: Yes
• 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
EGS	Handpiece, contra- and right-angle attachment, dental	Dental	872.4200	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44907	Ultrasonic dental scaling/debridement system handpiece	A hand-held component of an ultrasonic dental debridement system intended to convert high frequency electrical current from a generator into an ultrasonic oscillation, for a tip placed at its end to mechanically fragment and dislodge gross debris/accretions during an endodontic and/or periodontal procedure. It may also serve as a conduit for fluid intended to prevent overheating of the tip and surrounding tissue. This device is typically in the form of a pen/pencil with attached cables. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D0037400001	HIBCC