ADDaSEAL RE Adhesive Face Mask Strips 7154411

GUDID 00723896018897

Adhesive strip to be placed on the bridge of any face mask to create an airtight seal. Adhesive is repositionable on the skin side, making it better for sensitive skin and longer procedures.

PRACTICON, INC.

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

• Primary Device ID: 00723896018897
• NIH Device Record Key: 8c99d915-0a32-4dad-8a8d-784215ce2701
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ADDaSEAL RE Adhesive Face Mask Strips
• Version Model Number: 7154411
• Catalog Number: 7154411
• Company DUNS: 119193803
• Company Name: PRACTICON, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00723896018897 [Primary]

FDA Product Code

• LYU: Accessory, Surgical Apparel

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: 2023-06-19
• Device Publish Date: 2023-06-09

Devices Manufactured by PRACTICON, INC.

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• 00723896026694 - PRACTIFILM BARRIER FILM CLEAR: 2024-08-15 4" x 6" 1.5 mil polyethylene cling sheets that act as a barrier for contamination control. 1200 per role