Chewies 55-0160-0004

GUDID D78855016000040

Aligner Chewies Unscented

Gc Orthodontics America Inc.

Orthodontic aligner/retainer seater, single-use

• Primary Device ID: D78855016000040
• NIH Device Record Key: a2d64926-a8a4-41f7-9b4b-6922c88e1e07
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Chewies
• Version Model Number: 55-0160-0004
• Catalog Number: 55-0160-0004
• Company DUNS: 063167128
• Company Name: Gc Orthodontics America Inc.
• Device Count: 20
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D78855016000040 [Unit of Use]
HIBCC	D78855016000041 [Primary]

FDA Product Code

• ECS: PUSHER, BAND, 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: 2
• Public Version Date: 2023-04-04
• Device Publish Date: 2023-01-25

On-Brand Devices [Chewies]

• D78855016000040: Aligner Chewies Unscented
• D78855016000030: Aligner Chewies Watermelon Scented
• D78855016000020: Aligner Chewies Lemon Scented
• D78855016000010: Aligner Chewies Mint Scented