PureLife+ 2-Ply Dental Bibs

Basic Information

• Brand Name: PureLife+ 2-Ply Dental Bibs
• Primary DI: D79010920081
• Version / Model: 1092008
• Catalog Number: 1092008
• Company Name: PURELIFE, LLC
• Labeler DUNS: 828690904
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 500
• Record Status: Published
• Publish Date: 2023-06-08
• Public Version: 1
• Public Version Date: 2023-06-16
• Public Version Status: New
• Public Device Record Key: 3f2b104f-97d0-4926-a1a5-1c8395258ca0

Device Description

PureLife+ 2-Ply Dental Bibs, Yellow, 2-ply paper, 1-ply poly patient bibs, High-absorptancy and latex-fee, Horizontal embossing

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: Yes
• 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
62934	Surgical dressing/drape kit, single-use	A collection of various types of patient drapes, dressings, covers and/or towels intended to be used to facilitate a surgical procedure. It does not include any pharmaceuticals, surgical instruments, surgical tubing, or mechanically functional devices and is not dedicated to catheterization support. 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	D79010920080	HIBCC
Primary	D79010920081	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]