TRAUS SIP20

GUDID 08809260472181

Saeshin Precision Co., Ltd.

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• Primary Device ID: 08809260472181
• NIH Device Record Key: bcc8a506-6247-414f-8620-ef8ea5b72781
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRAUS SIP20
• Version Model Number: TRAUS BIP20
• 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	08809260472181 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201292

FDA Product Code

• EBW: Controller, Foot, Handpiece And Cord

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-03-02
• Device Publish Date: 2021-02-22

On-Brand Devices [TRAUS SIP20]

• 08809260472181: TRAUS BIP20
• 08809260471689: BIP20+MBP10SL+FUS10+CRB46LN