NAZORCAP Bite Guard

Basic Information

• Brand Name: NAZORCAP Bite Guard
• Primary DI: 00856824006083
• Version / Model: 1801
• Company Name: Nasorcap Medical, Inc.
• Labeler DUNS: 803689769
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-03-25
• Public Version: 4
• Public Version Date: 2024-01-23
• Public Version Status: Update
• Public Device Record Key: d541a50e-ccad-4b26-b30e-51f599c85d1c

Device Description

Bite Guard/Tubing Protector

Device Characteristics

• Single Use: Yes
• 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
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	00856824006083	GS1
Package	10856824006080	GS1	Box	50	In Commercial Distribution

Customer Contacts

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