Barrier

Basic Information

• Brand Name: Barrier
• Primary DI: H816DC0115S1
• Version / Model: DC-0115S
• Catalog Number: DC-0115S-1
• Company Name: CERTOL INTERNATIONAL, LLC
• Labeler DUNS: 095153714
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 300
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 5
• Public Version Date: 2022-11-01
• Public Version Status: Update
• Public Device Record Key: 42872f93-4783-4b3b-ac11-6e9a92d16a69

Device Description

Disposable dental bib connnector with tape

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: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• 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
KLC	Chair, Dental, With Operative Unit	Dental	872.6250	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
Package	H816DC0115S2	HIBCC	Case Box	10	In Commercial Distribution
Primary	H816DC0115S1	HIBCC
Unit of Use	H816DC0115S0	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K922175	000