ODP FACEMASK

GUDID 10190886000311

FACEMASK REPLACEMENT PAD

G & H Wire Company, Inc.

Orthodontic extraoral headgear

• Primary Device ID: 10190886000311
• NIH Device Record Key: 0b8eaaca-c70e-461e-923b-ce8c2b1eeda0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ODP FACEMASK
• Version Model Number: M546-01
• Company DUNS: 831465641
• Company Name: G & H Wire Company, Inc.
• Device Count: 1
• 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: 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

Customer Support Contacts

• Phone: +1(317)346-6655
• Email: orders@ghortho.com
• Phone: +1(317)346-6655
• Email: orders@ghortho.com
• Phone: +1(317)346-6655
• Email: orders@ghortho.com
• Phone: +1(317)346-6655
• Email: orders@ghortho.com
• Phone: +1(317)346-6655
• Email: orders@ghortho.com
• Phone: +1(317)346-6655
• Email: orders@ghortho.com
• Phone: +1(317)346-6655
• Email: orders@ghortho.com
• Phone: +1(317)346-6655
• Email: orders@ghortho.com
• Phone: +1(317)346-6655
• Email: orders@ghortho.com
• Phone: +1(317)346-6655
• Email: orders@ghortho.com
• Phone: +1(317)346-6655
• Email: orders@ghortho.com
• Phone: +1(317)346-6655
• Email: orders@ghortho.com
• Phone: +1(317)346-6655
• Email: orders@ghortho.com
• Phone: +1(317)346-6655
• Email: orders@ghortho.com
• Phone: +1(317)346-6655
• Email: orders@ghortho.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10190886000311 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111169

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: 5
• Public Version Date: 2025-04-01
• Device Publish Date: 2016-09-24

Devices Manufactured by G & H Wire Company, Inc.

• 00190886271028 - G&H ORTHODONTICS ®: 2026-03-09 AURALIS ROTH .018 UR1 +12°T +5°A 5PK
• 00190886271035 - G&H ORTHODONTICS ®: 2026-03-09 AURALIS ROTH .018 UL1 +12°T +5°A 5PK
• 00190886271042 - G&H ORTHODONTICS ®: 2026-03-09 AURALIS ROTH .018 UR2 +8°T +9°A 5PK
• 00190886271059 - G&H ORTHODONTICS ®: 2026-03-09 AURALIS ROTH .018 UL2 +8°T +9°A 5PK
• 00190886271066 - G&H ORTHODONTICS ®: 2026-03-09 AURALIS ROTH .018 UR3 HK 0°T 11°A 4°R 5 PK
• 00190886271073 - G&H ORTHODONTICS ®: 2026-03-09 AURALIS ROTH .018 UL3 HK 0°T 11°A 4°R 5 PK
• 00190886271080 - G&H ORTHODONTICS ®: 2026-03-09 AURALIS ROTH .018 UR4/5 HK -7°T 0°A 5PK
• 00190886271097 - G&H ORTHODONTICS ®: 2026-03-09 AURALIS ROTH .018 UL4/5 HK -7°T 0°A 5PK