Health-Tec/DHP Patient Bibs

Basic Information

• Brand Name: Health-Tec/DHP Patient Bibs
• Primary DI: D77364021401
• Version / Model: 640-2140
• Catalog Number: 640-2140
• Company Name: Dental Health Products Inc
• Labeler DUNS: 623191194
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 500
• Record Status: Published
• Publish Date: 2022-11-09
• Public Version: 1
• Public Version Date: 2022-11-17
• Public Version Status: New
• Public Device Record Key: 9275bd75-6ded-407c-8d95-7a8566297cc5

Device Description

Health-Tec/DHP Patient Bibs 2 Ply Paper + 1 Ply Poly Lavender 18" x 13" 500/case

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: Yes
• Has Manufacturing Date: Yes
• 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
Unit of Use	D77364021400	HIBCC
Primary	D77364021401	HIBCC