Barrier

Basic Information

• Brand Name: Barrier
• Primary DI: H816BB2930C1
• Version / Model: BB-2930C
• Catalog Number: BB-2930C-1
• Company Name: CERTOL INTERNATIONAL, LLC
• Labeler DUNS: 095153714
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 200
• 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: d4718468-1171-4b7c-807c-6b25630c004c

Device Description

29 x 30 Instrument / equipment drape chair sox

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
61049	Instrument/equipment drape, single-use, non-sterile	A non-sterile device made of natural and/or synthetic flexible materials intended to be used as a non-dedicated protective covering for various instruments/equipment (e.g., dental chairs, treatment tables), to provide a barrier against cross-contamination in the home or healthcare facility. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	H816BB2930C2	HIBCC		5	In Commercial Distribution
Primary	H816BB2930C1	HIBCC
Unit of Use	H816BB2930C0	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K922175	000