Multi-Adjustable Facemask®

GUDID 00190707108274

Facemask Replacement Pad Kit 2 Head/2Chin Foam/HexKey

ORTHO ORGANIZERS, INC.

Orthodontic extraoral headgear

• Primary Device ID: 00190707108274
• NIH Device Record Key: af6e8f21-9678-47d1-9c9c-328f26463052
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Multi-Adjustable Facemask®
• Version Model Number: 550-RK2
• Company DUNS: 062165188
• Company Name: ORTHO ORGANIZERS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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	00190707108274 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-10-03
• Device Publish Date: 2025-09-25

On-Brand Devices [Multi-Adjustable Facemask®]

• 00190707108274: Facemask Replacement Pad Kit 2 Head/2Chin Foam/HexKey
• 00190707108267: Facemask Replace PadKit Reg Camo 2 Head/2 Chin Foam/HexKey
• 00190707108250: Facemask Replace PadKit Pink Camo 2 Head/2 Chin Foam/HexKey
• 00190707108243: Facemask Replace Pad Kit Flame 2 Head/2 Chin Foam/HexKey
• 00190707108236: Facemask Replace PadKit Flower 2 Head/2 Chin Foam/HexKey
• 00190707108229: Multi-Adj Facemask Regular Camoflage MULTIADJUSTABLE
• 00190707108212: Multi-Adj Facemask Pink Camoflage MULTIADJUSTABLE
• 00190707108205: Multi-Adj Facemask Flame MULTIADJUSTABLE
• 00190707108199: Multi-Adj Facemask Flower MULTIADJUSTABLE
• 00190707108182: Multi-Adjustable Facemask Teal MULTIADJUSTABLE
• 00190707108175: Multi-Adj Facemask Pearl MULTIADJUSTABLE
• 00190707108168: Multi-Adjustable Facemask Clr MULTIADJUSTABLE
• 00190707108151: Multi-Adjustable Facemask Red MULTIADJUSTABLE
• 00190707108144: Multi-Adjustable Facemask Blue MULTIADJUSTABLE