HALO MOLAR BAND

Basic Information

• Brand Name: HALO MOLAR BAND
• Primary DI: D909901940S1
• Version / Model: MOLAR BAND .022 -14T BT W/SHEATH
• Catalog Number: 901-940S
• Company Name: Ortho Arch Company Inc
• Labeler DUNS: 020956330
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-10-25
• Public Version: 1
• Public Version Date: 2022-11-02
• Public Version Status: New
• Public Device Record Key: f133eca0-36e8-4d6e-a6f7-f285a7b45483

Device Description

U6R HALO MOLAR BAND .022 SGL CV -14T BT W/SHEATH

Device Characteristics

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

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
38734	Orthodontic metal band	A thin metal ring designed to be fitted around the contours of a tooth and cemented into place to support an orthodontic attachment (e.g., bracket, tube), brazed or soldered onto the ring, intended to be secured to the tooth. 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	D909901940S1	HIBCC