Rodney 55-0160-0155

GUDID D78855016001550

RODNEY SEATER CHEWIE (MINT) W/ROD

Gc Orthodontics America Inc.

Orthodontic aligner/retainer seater, single-use

• Primary Device ID: D78855016001550
• NIH Device Record Key: f84b4251-99a7-4d9f-a61c-366e3345a489
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rodney
• Version Model Number: 55-0160-0155
• Catalog Number: 55-0160-0155
• Company DUNS: 063167128
• Company Name: Gc Orthodontics America Inc.
• Device Count: 2
• 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)897-5589
• Email: GCOAInfo@gcorthodontics.com
• Phone: +1(708)897-5589
• Email: GCOAInfo@gcorthodontics.com
• Phone: +1(708)897-5589
• Email: GCOAInfo@gcorthodontics.com
• Phone: +1(708)897-5589
• Email: GCOAInfo@gcorthodontics.com
• Phone: +1(708)897-5589
• Email: GCOAInfo@gcorthodontics.com
• Phone: +1(708)897-5589
• Email: GCOAInfo@gcorthodontics.com
• Phone: +1(708)897-5589
• Email: GCOAInfo@gcorthodontics.com
• Phone: +1(708)897-5589
• Email: GCOAInfo@gcorthodontics.com
• Phone: +1(708)897-5589
• Email: GCOAInfo@gcorthodontics.com
• Phone: +1(708)897-5589
• Email: GCOAInfo@gcorthodontics.com
• Phone: +1(708)897-5589
• Email: GCOAInfo@gcorthodontics.com
• Phone: +1(708)897-5589
• Email: GCOAInfo@gcorthodontics.com
• Phone: +1(708)897-5589
• Email: GCOAInfo@gcorthodontics.com
• Phone: +1(708)897-5589
• Email: GCOAInfo@gcorthodontics.com
• Phone: +1(708)897-5589
• Email: GCOAInfo@gcorthodontics.com
• Phone: +1(708)897-5589
• Email: GCOAInfo@gcorthodontics.com
• Phone: +1(708)897-5589
• Email: GCOAInfo@gcorthodontics.com
• Phone: +1(708)897-5589
• Email: GCOAInfo@gcorthodontics.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D78855016001550 [Unit of Use]
HIBCC	D78855016001551 [Primary]

FDA Product Code

• ECS: PUSHER, BAND, 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

Devices Manufactured by Gc Orthodontics America Inc.

• D78811201CC511201 - EXPERIENCE: 2023-04-07 EXP C U/L 5-5 L 3-3 EXP M L 4,5 HK 345
• D78811202AA597521 - EXPERIENCE: 2023-04-07 EXPC CCO U5-5 EXPM MBT L5-5 022 hks345
• D78812202AA519151 - EXPERIENCE: 2023-04-07 EXCM U5-5 EXPM L5-5 MBT 022 HK345
• D788122C0500101 - EXPERIENCE: 2023-04-07 EXMC ROTH 022 U5-5 HK 345
• D788151CC5S0101 - CHIC: 2023-04-07 CHIC MINI ROTH 018 HK 3,4,5
• D788152CC5S0101 - CHIC: 2023-04-07 CHIC MINI ROTH 018 HK 3,4,5
• D788312BB5GP201 - LEGEND: 2023-04-07 LMI GOLD MBT 022 U/L 6-6 HK 345
• D788312CC542191 - LEGEND: 2023-04-07 LMI ROTH U 2-2 MBT 345 HK 345