G&H STANDARD FACEBOW

GUDID 10190886000137

SS FACEBOW, SZ 1, MED

G & H Wire Company, Inc.

Orthodontic face bow

• Primary Device ID: 10190886000137
• NIH Device Record Key: 4c433c48-b1bd-4ee3-aa93-0e857e1f7fe0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: G&H STANDARD FACEBOW
• Version Model Number: STFB01
• 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	10190886000137 [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

On-Brand Devices [G&H STANDARD FACEBOW]

• 10190886000236: SS FACEBOW, SZ 5, SHORT
• 10190886000229: SS FACEBOW, SZ 4, SHORT
• 10190886000212: SS FACEBOW, SZ 3, SHORT
• 10190886000205: SS FACEBOW, SZ 2, SHORT
• 10190886000199: SS FACEBOW, SZ 1, SHORT
• 10190886000182: SS FACEBOW, UNIV, SHORT
• 10190886000175: SS FACEBOW, SZ 5, MED
• 10190886000168: SS FACEBOW, SZ 4, MED
• 10190886000151: SS FACEBOW, SZ 3, MED
• 10190886000144: SS FACEBOW, SZ 2, MED
• 10190886000137: SS FACEBOW, SZ 1, MED
• 10190886000120: SS FACEBOW, UNIV, MED