Plasdent

Basic Information

• Brand Name: Plasdent
• Primary DI: D832PS850S1
• Version / Model: PS850S
• Catalog Number: PS850S
• Company Name: PLASDENT CORPORATION
• Labeler DUNS: 190377184
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 200
• Record Status: Published
• Publish Date: 2022-08-30
• Public Version: 1
• Public Version Date: 2022-09-07
• Public Version Status: New
• Public Device Record Key: 966c9b1a-e60f-4447-a66e-0293c97dddbe

Device Description

Biohazard Bags, Stick-On, Red, 6" X 6"

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
12223	Bucket liner	A device used to line a bucket in order to create a barrier to contamination and serve as the basis for preventing cross-contamination, reducing cleaning requirements, and protecting the bucket surface finish. This liner will typically be used in swab buckets, commonly known as kick buckets. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	D832PS850S2	HIBCC	Case	16	In Commercial Distribution
Primary	D832PS850S1	HIBCC
Unit of Use	D832PS850S0	HIBCC