Multi-Adjustable Facemask

GUDID 00190707097714

Multi-Adjustable Facemask-Pearl

Ortho Organizers, Inc.

Orthodontic extraoral headgear

• Primary Device ID: 00190707097714
• NIH Device Record Key: ba1eed3d-74cb-4638-8a27-ca2ab001fc06
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Multi-Adjustable Facemask
• Version Model Number: 426-058
• Company DUNS: 062165188
• Company Name: Ortho Organizers, Inc.
• Device Count: 1
• DM Exempt: true
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00190707097714 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K000358

FDA Product Code

• DZB: Headgear, extraoral, orthodontic

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: 2025-12-19
• Device Publish Date: 2022-01-06

On-Brand Devices [Multi-Adjustable Facemask]

• 00190707097714: Multi-Adjustable Facemask-Pearl
• 00190707097707: Multi-Adjustable Facemask-Teal
• 00190707097691: Multi-Adjustable Facemask-Red
• 00190707097684: Multi-Adjustable Facemask-Blue