Masel

Basic Information

• Brand Name: Masel
• Primary DI: 00190707007775
• Version / Model: 4001-024
• Company Name: ORTHO ORGANIZERS, INC.
• Labeler DUNS: 062165188
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-09-08
• Public Version: 3
• Public Version Date: 2018-10-05
• Public Version Status: Update
• Public Device Record Key: 0098bb3f-64aa-4de7-af0f-d94c71b7b023

Device Description

CHILD CHEEK RETRACTOR EXTRAORAL

Device Characteristics

• Single Use: No
• 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: Yes
• 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
EIG	RETRACTOR, ALL TYPES	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44828	Dental cheek retractor, professional, reusable	A hands-free, self-retaining frame intended to allow a dental professional to retract the lips/cheeks of a patient during an orthodontic or restorative dental procedure for easy access to the field of operation. It is designed to be placed in and around the lips/cheeks and may also be designed to displace the tongue. It is a synthetic polymer device which may include suction adaptors/tubing for saliva removal to maintain a dry field. It is not intended to be placed between the teeth (i.e., not a mouth gag). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00190707007775	GS1