3D

Basic Information

• Brand Name: 3D
• Primary DI: 00885797084446
• Version / Model: A04254
• Company Name: Rmo, Inc.
• Labeler DUNS: 007058183
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 3
• Record Status: Published
• Publish Date: 2024-08-15
• Public Version: 1
• Public Version Date: 2024-08-23
• Public Version Status: New
• Public Device Record Key: 124f6a97-bb62-4889-a52f-431aef488397

Device Description

3D LINGUAL ARCH SZ5 DIST BEND

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: 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
DYT	Maintainer, Space Preformed, Orthodontic	Dental	872.5525	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
Unit of Use	00000008857972	GS1
Primary	00885797084446	GS1