Sanda

GUDID 06972712651068

Xiantao Sanda Industrial Co.,Ltd.

Surgical/medical face mask, non-antimicrobial, single-use

• Primary Device ID: 06972712651068
• NIH Device Record Key: cfbcfecd-5ae5-45e7-adf5-ff65d46d6aea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sanda
• Version Model Number: SD-1001
• Company DUNS: 547087114
• Company Name: Xiantao Sanda Industrial 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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	06972712651068 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222651

FDA Product Code

• FXX: Mask, Surgical

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: 2023-04-24
• Device Publish Date: 2023-04-14

On-Brand Devices [Sanda]

• 06972712651013: SD-1003
• 06972712651068: SD-1001