OPSoft® Mouthguards for laser (10 units)

Basic Information

• Brand Name: OPSoft® Mouthguards for laser (10 units)
• Primary DI: 20697660004864
• Version / Model: 60-104
• Company Name: Oculo-Plastik Inc
• Labeler DUNS: 257382580
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-11-25
• Public Version: 1
• Public Version Date: 2019-12-03
• Public Version Status: New
• Public Device Record Key: c2f7becc-ec61-41e4-ad2e-491ab621aad0

Device Description

The OPSoft mouthguard is intended for protection during hair removal, cutaneous treatment, and perioral procedures with laser, IPL or RF.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
BRW	Protector, Dental	Anesthesiology	868.5820	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63415	Laser protective mouthguard	A sterile, preformed oral device designed to protect tooth enamel from the adverse side effects of laser treatment administered to other parts of the head/neck. It is made of synthetic materials (e.g., silicone). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	20697660004864	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Width	4.5	Centimeter
Length	12	Centimeter