Unico High Performance Surgical Mask With Face Shield

GUDID 08809783490518

UNICO GLOBAL INC

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• Primary Device ID: 08809783490518
• NIH Device Record Key: 98a048cf-0a86-41b6-b43c-0d28d3feee07
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Unico High Performance Surgical Mask With Face Shield
• Version Model Number: SM-301FST
• Company DUNS: 690513726
• Company Name: UNICO GLOBAL INC
• Device Count: 25
• 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809783490518 [Unit of Use]
GS1	08809783490617 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210147

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: 2022-03-28
• Device Publish Date: 2022-03-18

On-Brand Devices [Unico High Performance Surgical Mask With Face Shield]

• 08809783490518: SM-301FST
• 08809783490501: SM-301FS