TRAUS

Basic Information

• Brand Name: TRAUS
• Primary DI: 08809260475502
• Version / Model: TST10XX
• Company Name: Saeshin Precision Co., Ltd.
• Labeler DUNS: 688019566
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-04-01
• Public Version: 1
• Public Version Date: 2026-04-09
• Public Version Status: New
• Public Device Record Key: 3412ab8b-a4c9-4d46-82e6-876905069440

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: 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
HBC	Motor, Drill, Electric	Neurology	882.4360	2

GMDN Terms

Code	Name	Definition	Implantable	Status
66243	Bone/joint surgical power tool motorized handpiece/set, electric, reusable	An electrically-powered one-piece device or modular device collection designed to accept an endpiece(s) [e.g., drill bit, saw blade, bur] for drilling, cutting, and/or inserting procedures involving bones and tough tissues during a surgical procedure; it is not dedicated to dental procedures. It includes an electric motor and typically one or more power tool attachments with a Jacobs chuck or quick-connect collet/adaptor at its distal end to connect 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	08809260475502	GS1

Premarket Submissions

Submission Number	Supplement Number
K233153	000