Plasdent

Basic Information

• Brand Name: Plasdent
• Primary DI: D832PAPB101
• Version / Model: PAP-B10
• Catalog Number: PAP-B10
• Company Name: PLASDENT CORPORATION
• Labeler DUNS: 190377184
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1000
• Record Status: Published
• Publish Date: 2022-03-24
• Public Version: 1
• Public Version Date: 2022-04-01
• Public Version Status: New
• Public Device Record Key: 11104a77-bd08-4277-95d5-782e8f789a25

Device Description

Tray Paper, B, 8 1/2" X 12 1/4", Mauve

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
64367	Instrument tray cover, single-use	A flexible, synthetic polymer cover designed to be placed on an instrument tray to provide a protective barrier for the transport and short-term storage of clinical instruments (typically endoscopes or surgical instruments). It is typically available in two colours to indicate clean/sterile or contaminated; a tray liner is typically supplied with the device. 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	D832PAPB100	HIBCC
Primary	D832PAPB101	HIBCC
Package	D832PAPB102	HIBCC	Case	3	In Commercial Distribution