Henry Schein 5700739

GUDID 20304040117198

HSI Earloop Mask Level 1

HENRY SCHEIN, INC.

Surgical/medical face mask, single-use

• Primary Device ID: 20304040117198
• NIH Device Record Key: 65aa9dbb-ef6f-4563-9d8a-91ed4efd8043
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Henry Schein
• Version Model Number: 5700739
• Catalog Number: 5700739
• Company DUNS: 012430880
• Company Name: HENRY SCHEIN, INC.
• Device Count: 50
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00304040117194 [Unit of Use]
GS1	10304040117191 [Primary]
GS1	20304040117198 [Package]; Contains: 10304040117191; Package: Case [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051291

FDA Product Code

• FXX: Mask, surgical

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-05-06
• Device Publish Date: 2019-10-30

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