RCM-18-501

Basic Information

• Brand Name: RCM-18-501
• Primary DI: 08800046017138
• Version / Model: RCM-18-501
• Company Name: GNI Co.,Ltd
• Labeler DUNS: 694828541
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-15
• Public Version: 1
• Public Version Date: 2022-12-23
• Public Version Status: New
• Public Device Record Key: 68ae7747-60ed-495d-a2ec-c5dad85a2d53

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• 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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NJM	Bracket, Ceramic, Orthodontic	Dental	872.5470	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58818	Self-ligating orthodontic bracket	A ceramic device intended to be bonded to a tooth to hold an orthodontic archwire used to apply pressure to the tooth in order to alter the position of the tooth. It has an integral fixation clip, typically made of a polymer with a metal hinge, to retain the archwire (self-ligating) within a metal insert slot. 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	08800046017138	GS1

Premarket Submissions

Submission Number	Supplement Number
K201410	000