Lip Bumper

Basic Information

• Brand Name: Lip Bumper
• Primary DI: E53563210100151
• Version / Model: 63-2101-0015
• Catalog Number: 63-2101-0015
• Company Name: Gc Orthodontics America Inc.
• Labeler DUNS: 063167128
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-01-07
• Public Version: 2
• Public Version Date: 2022-08-10
• Public Version Status: Update
• Public Device Record Key: b614b31c-3d58-4783-aac7-166105c15946
• Distribution End Date: 2022-08-09

Device Description

CG Lip Bump High ANG 5

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DZC	WIRE, ORTHODONTIC	Dental	872.5410	1

GMDN Terms

Code	Name	Definition	Implantable	Status
41397	Orthodontic archwire	A dental wire in the shape of an arch used with orthodontic attachments (orthodontic brackets) that are affixed to the crowns/surfaces of two or more teeth in order to cause/guide tooth movement. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	E53563210100151	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]