Safco Contour 4-ply fitted bibs

Basic Information

• Brand Name: Safco Contour 4-ply fitted bibs
• Primary DI: D72322161343
• Version / Model: 2216134
• Catalog Number: 2216134
• Company Name: SAFCO DENTAL SUPPLY CO.
• Labeler DUNS: 020417380
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 400
• Record Status: Published
• Publish Date: 2021-12-02
• Public Version: 1
• Public Version Date: 2021-12-10
• Public Version Status: New
• Public Device Record Key: 80c28470-9b3d-4b0b-a405-30a67262d545

Device Description

Safco Contour bib 18x22 blue 400/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: 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
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	D72322161340	HIBCC
Primary	D72322161343	HIBCC