Procedure Face Mask with Ear Loop and Plastic Shield

GUDID 00616784220239

DYNAREX CORPORATION

Surgical/medical face mask, single-use

• Primary Device ID: 00616784220239
• NIH Device Record Key: bd957130-3de6-4f7f-ab87-fba076f01ac7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Procedure Face Mask with Ear Loop and Plastic Shield
• Version Model Number: 2202
• Company DUNS: 008124539
• Company Name: DYNAREX CORPORATION
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00616784220215 [Unit of Use]
GS1	00616784220222 [Primary]
GS1	00616784220239 [Package]; Contains: 00616784220222; Package: [4 Units]; In Commercial Distribution
GS1	00810180843911 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133070

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: 4
• Public Version Date: 2020-05-06
• Device Publish Date: 2016-09-24

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