SOF-GEAR CHIN CUP

GUDID 10190886000427

CHIN CUP

G & H Wire Company, Inc.

Orthodontic extraoral headgear

• Primary Device ID: 10190886000427
• NIH Device Record Key: a9dafe51-4028-4117-81e0-0e1d46d64628
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SOF-GEAR CHIN CUP
• Version Model Number: SOF-CC
• Company DUNS: 831465641
• Company Name: G & H Wire Company, Inc.
• Device Count: 5
• 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	00190886000420 [Unit of Use]
GS1	10190886000427 [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.

• 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: 2025-04-08 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