Polyback Contour Bibs

Basic Information

• Brand Name: Polyback Contour Bibs
• Primary DI: 50732224003691
• Version / Model: WERUECGR
• Company Name: CROSSTEX INTERNATIONAL, INC.
• Labeler DUNS: 057728685
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 400
• Record Status: Published
• Publish Date: 2022-10-31
• Public Version: 1
• Public Version Date: 2022-11-08
• Public Version Status: New
• Public Device Record Key: b671563b-11e4-467c-ae50-001c87f64b2e

Device Description

Bibs, Green, 2 Ply Tissue with 1 Ply Poly, 19 in x 13 in

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: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
61048	Patient examination/treatment drape, single-use	A non-sterile, noninvasive flat sheet designed to cover a portion of a patient’s anatomy during an examination or non-surgical treatment procedure in the home or healthcare facility primarily to prevent soiling/cross-contamination; it is not intended for surgical use. 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	00732224003696	GS1
Primary	50732224003691	GS1

Customer Contacts

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