ELASTICS

Basic Information

• Brand Name: ELASTICS
• Primary DI: E53585083111111
• Version / Model: 85-0831-1111
• Catalog Number: 85-0831-1111
• Company Name: Gc Orthodontics America Inc.
• Labeler DUNS: 063167128
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5000
• Record Status: Published
• Publish Date: 2021-08-26
• Public Version: 1
• Public Version Date: 2021-09-03
• Public Version Status: New
• Public Device Record Key: c61876d2-59e0-4dc0-a954-a85be2a5cf74

Device Description

ELASTICS MD 8MM 4OZ Clarinet 5/16 (NEON)

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
ECI	BAND, ELASTIC, ORTHODONTIC	Dental	872.5410	1

GMDN Terms

Code	Name	Definition	Implantable	Status
41677	Orthodontic archwire/bracket ligature	A device intended to securely tether an orthodontic archwire to an orthodontic bracket, or securely hold the archwire in the archwire slot of an orthodontic bracket (or brace). It is in the form of a small single tie, or a circular band made of elastomeric (e.g., polyurethane, rubber) or metal materials. This is a single-patient device intended to be replaced regularly during orthodontic treatment (single-use).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	E53585083111110	HIBCC
Primary	E53585083111111	HIBCC

Customer Contacts

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