ORTHOMETRIC BANDS

Basic Information

• Brand Name: ORTHOMETRIC BANDS
• Primary DI: 07908470700501
• Version / Model: 40.01.0390
• Catalog Number: 40.01.0390
• Company Name: ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA
• Labeler DUNS: 898330003
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-09-28
• Public Version: 1
• Public Version Date: 2022-10-06
• Public Version Status: New
• Public Device Record Key: cae0517c-1975-4767-b368-b08de7ec974b

Device Description

ORTHODONTIC BANDS- LOWER 39 MM

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
DYO	Band, Material, Orthodontic	Dental	872.5410	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46338	Orthodontic band material	A material typically supplied in the form of rolls, strips, or precut blanks with the attachments in place ready to be configured as orthodontic bands. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07908470700501	GS1