Plasdent

Basic Information

• Brand Name: Plasdent
• Primary DI: D832PAPC11
• Version / Model: PAP-C1
• Catalog Number: PAP-C1
• 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: 00c1d3c2-a580-4deb-a5f7-bc760800e35c

Device Description

Tray Paper, C, 11" X 17 1/4", White

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
Package	D832PAPC12	HIBCC	Case	3	In Commercial Distribution
Primary	D832PAPC11	HIBCC
Unit of Use	D832PAPC10	HIBCC