Giggle Monster Face Masks 7147610

GUDID 00723896016138

Level 2 Dental Earloop Facemask

PRACTICON, INC.

Surgical/medical face mask, single-use

• Primary Device ID: 00723896016138
• NIH Device Record Key: dc771a82-a821-42ee-915f-e058e38f147c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Giggle Monster Face Masks
• Version Model Number: 7147610
• Catalog Number: 7147610
• Company DUNS: 119193803
• Company Name: PRACTICON, INC.
• Device Count: 48
• 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: false
• 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	00723896007303 [Unit of Use]
GS1	00723896016121 [Primary]
GS1	00723896016138 [Package]; Contains: 00723896016121; Package: Case [40 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182514

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: 2020-01-07

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