SCPC

GUDID 06941548900176

The Medical Surgical Mask is a single use, three-layer, flat-pleated style surgical mask with ear loops and nose piece. The mask is manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. The surgical masks is held over the user’s mouth and nose via earloops made of nylon with spandex. The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of malleable polyethylene wire. The medical surgical mask includes blue colorant, Shining Blue R603. The medical surgical mask is sold non-sterile and is intended to be single use, and disposable.

SICHUAN PHARMACEUTICAL.INC

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• Primary Device ID: 06941548900176
• NIH Device Record Key: 7eb755c4-cfbb-4bfc-954f-9b15a653d408
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SCPC
• Version Model Number: Ear Loops, Flat Pleated, 3 layers
• Company DUNS: 529113561
• Company Name: SICHUAN PHARMACEUTICAL.INC
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06941548900176 [Package]; Contains: 06941548991327; Package: Box [5 Units]; In Commercial Distribution
GS1	06941548991327 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210813

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: 2021-12-09
• Device Publish Date: 2021-12-01