Midwest® Endo

Basic Information

• Brand Name: Midwest® Endo
• Primary DI: E2768752250
• Version / Model: 875225
• Company Name: SIRONA Dental Systems GmbH
• Labeler DUNS: 340306351
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-08-30
• Public Version: 2
• Public Version Date: 2022-05-17
• Public Version Status: Update
• Public Device Record Key: 197f9db8-3a71-4fa9-b333-e3573e24509e

Device Description

Midwest® Endo 6:1

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: Yes
• 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
EGS	Handpiece, Contra- And Right-Angle Attachment, Dental	Dental	872.4200	1

GMDN Terms

Code	Name	Definition	Implantable	Status
38611	Dental power tool system handpiece, remotely-driven	A hand-held dental device that includes a chuck for attaching a rotary dental endpiece (e.g., drill bits, burs, reamers) intended to be used in dentistry to bore/excavate bones, teeth, and tough tissues. The device does not incorporate a power source (e.g., an AC-powered motor). The rotational power is transferred from the power source to the endpiece via mechanical components (e.g., chains, gears, shafts) incorporated in the handpiece or via an external flexible drive system (e.g., a Bowden cable); the endpiece(s) are not included. This is a reusable device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	E2768752250	HIBCC

Customer Contacts

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