SunMed

Basic Information

• Brand Name: SunMed
• Primary DI: 10889483231135
• Version / Model: TP-50-I
• Catalog Number: TP-50-I
• Company Name: SUNMED, LLC
• Labeler DUNS: 069009268
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-07-18
• Public Version: 1
• Public Version Date: 2023-07-26
• Public Version Status: New
• Public Device Record Key: 9419445b-0301-4c41-a1ba-0b1b0ff3acf1

Device Description

TOOTH PROTECTOR INDIVIDUAL WRAPPED 50/PK

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: Yes
• 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
BRW	Protector, dental	Anesthesiology	868.5820	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46492	Mouthguard, single-use	A prefabricated oral device designed to protect the teeth, bones, and tissues of the mouth from damage due to impact/trauma typically during surgery or intubation. It is made of standard, preformed materials or items for adaptation to/direct insertion into the mouth. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10889483231135	GS1

Customer Contacts

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