TRAUS Dental Handpiece

GUDID 08809260471566

20:1, Non-Optic

Saeshin Precision Co., Ltd.

Dental power tool system, line-powered

• Primary Device ID: 08809260471566
• NIH Device Record Key: f806187b-6087-4c36-84ac-7d32217c1132
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRAUS Dental Handpiece
• Version Model Number: TRAUS CRB46NN
• Company DUNS: 688019566
• Company Name: Saeshin Precision Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809260471566 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182892

FDA Product Code

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

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[08809260471566]

Moist Heat or Steam Sterilization

[08809260471566]

Moist Heat or Steam Sterilization

[08809260471566]

Moist Heat or Steam Sterilization

[08809260471566]

Moist Heat or Steam Sterilization

[08809260471566]

Moist Heat or Steam Sterilization

[08809260471566]

Moist Heat or Steam Sterilization

[08809260471566]

Moist Heat or Steam Sterilization

[08809260471566]

Moist Heat or Steam Sterilization

[08809260471566]

Moist Heat or Steam Sterilization

[08809260471566]

Moist Heat or Steam Sterilization

[08809260471566]

Moist Heat or Steam Sterilization

[08809260471566]

Moist Heat or Steam Sterilization

[08809260471566]

Moist Heat or Steam Sterilization

[08809260471566]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-12-30
• Device Publish Date: 2020-12-22

On-Brand Devices [TRAUS Dental Handpiece]

• 08809260471566: 20:1, Non-Optic
• 08809260471559: '20:1, Optic