TRAUS

GUDID 08809260471191

Angle Handpiece, Button type

Saeshin Precision Co., Ltd.

Dental power tool system, line-powered

• Primary Device ID: 08809260471191
• NIH Device Record Key: f4f3da03-060b-4f4c-ae17-77ba083562fe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRAUS
• Version Model Number: ACL(B)-01C
• 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	08809260471191 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100192

FDA Product Code

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

Sterilization

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

[08809260471191]

Moist Heat or Steam Sterilization

[08809260471191]

Moist Heat or Steam Sterilization

[08809260471191]

Moist Heat or Steam Sterilization

[08809260471191]

Moist Heat or Steam Sterilization

[08809260471191]

Moist Heat or Steam Sterilization

[08809260471191]

Moist Heat or Steam Sterilization

[08809260471191]

Moist Heat or Steam Sterilization

[08809260471191]

Moist Heat or Steam Sterilization

[08809260471191]

Moist Heat or Steam Sterilization

[08809260471191]

Moist Heat or Steam Sterilization

[08809260471191]

Moist Heat or Steam Sterilization

[08809260471191]

Moist Heat or Steam Sterilization

[08809260471191]

Moist Heat or Steam Sterilization

[08809260471191]

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]

• 08809260471214: Angle Handpiece Non-Optic 1:1
• 08809260471207: Angle Handpiece 1:1
• 08809260471191: Angle Handpiece, Button type