Masel

Basic Information

• Brand Name: Masel
• Primary DI: 00190707000554
• Version / Model: 3904-200
• Company Name: ORTHO ORGANIZERS, INC.
• Labeler DUNS: 062165188
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 7e8806e0-8036-4229-8c8e-1d67455a5dd7

Device Description

FACEBOW 045 ONE FOR ALL

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: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
DZB	Headgear, extraoral, orthodontic	Dental	872.5500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
40468	Orthodontic face bow	A dental device used in conjunction with extraoral traction anchored on the back of the head or neck, as a long metal bow that inserts intraorally into an orthodontic appliance. Generally used to move teeth or bones posteriorly or prevent their forward movement.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00190707000554	GS1

Premarket Submissions

Submission Number	Supplement Number
K980195	000