DTE

Basic Information

• Brand Name: DTE
• Primary DI: 06944843616193
• Version / Model: Endo Space
• Company Name: Guilin Woodpecker Medical Instrument Co., Ltd.
• Labeler DUNS: 545272577
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-10-17
• Public Version: 1
• Public Version Date: 2024-10-25
• Public Version Status: New
• Public Device Record Key: f8a14e31-ccc9-4c2b-bef7-d454872b1207

Device Description

endo motor

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: 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
EKX	Handpiece, Direct Drive, Ac-Powered	Dental	872.4200	1

GMDN Terms

Code	Name	Definition	Implantable	Status
66245	Dental surgical power tool motorized handpiece/set, electric	An electrically-powered one-piece device or modular device collection designed to accept an endpiece(s) [e.g., drill bit, saw blade] for drilling, cutting, polishing, and/or inserting procedures involving bones and tough tissues during a dental surgical procedure. It includes an electric motor and the appropriate attachments (e.g., angle adaptor, torque multiplier) at its distal end for connection of the endpieces and may include a rechargeable battery or a control unit; the endpieces are not included. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06944843616193	GS1

Premarket Submissions

Submission Number	Supplement Number
K203320	000