MIDWEST®

Basic Information

• Brand Name: MIDWEST®
• Primary DI: D00390702PK031
• Version / Model: 90702PK03
• Company Name: Dentsply Professional
• Labeler DUNS: 144140845
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-11-11
• Public Version: 3
• Public Version Date: 2023-02-08
• Public Version Status: Update
• Public Device Record Key: ad518612-5ea1-43c1-a2ff-44446e8f09df
• Distribution End Date: 2022-12-22

Device Description

MIDWEST® RDH Freedom® Cordless Prophy System, Premium System - Pink. Contains: 3 Sheaths, 200 NUPRO Freedom® Disposable Prophy Angles and 1 Disposa-Shield ® Trial Pack.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PEM	Dental barriers and sleeves	General, Plastic Surgery	878.4370	2
EKX	HANDPIECE, DIRECT DRIVE, AC-POWERED	Dental	872.4200	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63978	Dental power tool non-rotary polishing endpiece	An oscillating, sagittal, or reciprocating dental instrument designed to be attached to a dedicated dental power tool handpiece to perform a specific final mechanical function (e.g., polishing, contouring, finishing) during an orthodontic procedure (e.g., interproximal reduction). It is a metallic flat endpiece in the form of a blade; some types may be diamond coated. This is a reusable device.	No	Active
66247	Dental power tool handpiece motorless component	A component of a dental power tool handpiece designed to connect between a dental power tool motor and an endpiece to transfer mechanical energy from the motor to the endpiece during a dental surgical procedure. It may be in the form of a torque multiplier, adapter, or motorless handpiece. Neither the motor nor the endpiece is included. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D00390702PK031	HIBCC

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Atmospheric limitations 500 to 1060 hPa.