MULTI FA 92-5005-0000

GUDID D78892500500001

MULTI FA CRIMPABLE STOP (x10)

Gc Orthodontics America Inc.

Orthodontic spring

• Primary Device ID: D78892500500001
• NIH Device Record Key: 56d83a5e-baf7-4910-ae8f-8c9275831793
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MULTI FA
• Version Model Number: 92-5005-0000
• Catalog Number: 92-5005-0000
• Company DUNS: 063167128
• Company Name: Gc Orthodontics America Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• 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(708)897-8859
• Email: GCOAInfo@gcorthodontics.com
• Phone: +1(708)897-8859
• Email: GCOAInfo@gcorthodontics.com
• Phone: +1(708)897-8859
• Email: GCOAInfo@gcorthodontics.com
• Phone: +1(708)897-8859
• Email: GCOAInfo@gcorthodontics.com
• Phone: +1(708)897-8859
• Email: GCOAInfo@gcorthodontics.com
• Phone: +1(708)897-8859
• Email: GCOAInfo@gcorthodontics.com
• Phone: +1(708)897-8859
• Email: GCOAInfo@gcorthodontics.com
• Phone: +1(708)897-8859
• Email: GCOAInfo@gcorthodontics.com
• Phone: +1(708)897-8859
• Email: GCOAInfo@gcorthodontics.com
• Phone: +1(708)897-8859
• Email: GCOAInfo@gcorthodontics.com
• Phone: +1(708)897-8859
• Email: GCOAInfo@gcorthodontics.com
• Phone: +1(708)897-8859
• Email: GCOAInfo@gcorthodontics.com
• Phone: +1(708)897-8859
• Email: GCOAInfo@gcorthodontics.com
• Phone: +1(708)897-8859
• Email: GCOAInfo@gcorthodontics.com
• Phone: +1(708)897-8859
• Email: GCOAInfo@gcorthodontics.com
• Phone: +1(708)897-8859
• Email: GCOAInfo@gcorthodontics.com
• Phone: +1(708)897-8859
• Email: GCOAInfo@gcorthodontics.com
• Phone: +1(708)897-8859
• Email: GCOAInfo@gcorthodontics.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D78892500500001 [Primary]

FDA Product Code

• DYJ: RETAINER, SCREW EXPANSION, 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: 2023-04-07
• Device Publish Date: 2023-03-30

On-Brand Devices [MULTI FA]

• D78892500500001: MULTI FA CRIMPABLE STOP (x10)
• D78892500400001: MULTI FA BAND-R (LEFT & RIGHT)
• D78892500300001: MULTI FA LONG (LEFT & RIGHT)
• D78892500200001: MULTI FA SHORT (LEFT & RIGHT)
• D78892500100001: MULTI FA REGULAR (LEFT & RIGHT)