Britedent

Basic Information

• Brand Name: Britedent
• Primary DI: D974BSI24271
• Version / Model: BSI-2427
• Company Name: Bright Supply, Inc.
• Labeler DUNS: 124117012
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 500
• Record Status: Published
• Publish Date: 2020-11-26
• Public Version: 2
• Public Version Date: 2021-01-11
• Public Version Status: Update
• Public Device Record Key: fdec6127-1ce7-4f62-9a95-5883e05bbd48

Device Description

Disposable Dental Bib White 13" x 18" (500 bibs)

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: No
• MRI Safety: MR Safe
• 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
KHR	Absorber, Saliva, Paper	Dental	872.6050	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61050	Dental bib	A non-sterile device intended to be worn by a patient during a dental examination or treatment procedure to function as a barrier to soiling and cross-contamination. It typically consists of a shaped piece of natural and/or synthetic material intended to be fastened around the neck and cover the front side of the upper body. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D974BSI24271	HIBCC
Unit of Use	D974BSI24270	HIBCC