Plasdent

Basic Information

• Brand Name: Plasdent
• Primary DI: D832BIBBND1
• Version / Model: BIB-BND
• Catalog Number: BIB-BND
• Company Name: PLASDENT CORPORATION
• Labeler DUNS: 190377184
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 250
• Record Status: Published
• Publish Date: 2022-03-24
• Public Version: 1
• Public Version Date: 2022-04-01
• Public Version Status: New
• Public Device Record Key: 4669107a-c8d6-481a-8281-a37640cbdfc7

Device Description

Biband Disposable Bib Band, White

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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• 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
NRD	Unit, Operative Dental, Accessories	Dental	872.6640	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
Unit of Use	D832BIBBND0	HIBCC
Primary	D832BIBBND1	HIBCC