GUDID 10190886051306

ORANGE COATED FACEBOW, UNIV

G & H Wire Company, Inc.

Orthodontic face bow

• Primary Device ID: 10190886051306
• NIH Device Record Key: a3b3f222-98fa-4b80-aff4-5f5bd4345609
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: CCFB004
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10190886051306 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-04-08
• Device Publish Date: 2025-03-31

Devices Manufactured by G & H Wire Company, Inc.

• 10190886051276 - NA: 2025-04-08 BLACK COATED FACEBOW, UNIV
• 10190886051283 - NA: 2025-04-08 BLUE COATED FACEBOW, UNIV
• 10190886051290 - NA: 2025-04-08 WHITE COATED FACEBOW, UNIV
• 10190886051306 - NA: 2025-04-08ORANGE COATED FACEBOW, UNIV
• 10190886051306 - NA: 2025-04-08 ORANGE COATED FACEBOW, UNIV
• 10190886051313 - NA: 2025-04-08 DARK GREEN COATED FACEBOW, UNIV
• 10190886051320 - NA: 2025-04-08 LIME GREEN COATED FACEBOW, UNIV
• 10190886051337 - NA: 2025-04-08 YELLOW COATED FACEBOW, UNIV
• 10190886051344 - NA: 2025-04-08 PURPLE COATED FACEBOW, UNIV