Plasdent

Basic Information

• Brand Name: Plasdent
• Primary DI: D832PS328T1
• Version / Model: PS328T
• Catalog Number: PS328T
• Company Name: PLASDENT CORPORATION
• Labeler DUNS: 190377184
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 500
• Record Status: Published
• Publish Date: 2022-06-16
• Public Version: 2
• Public Version Date: 2022-11-09
• Public Version Status: Update
• Public Device Record Key: abb8058a-9a88-4f54-8979-7c7007c961bf

Device Description

T-Shape Lite Handle Cover, 6"W X 3"L

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: No
• 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
PEM	Dental Barriers And Sleeves	General, Plastic Surgery	878.4370	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44977	Medical equipment handle cover, single-use	A device designed specifically to cover the handle of a piece of medical equipment (e.g., operating light) to provide a physical sterile barrier between the handle and the hand of a healthcare professional, e.g., during a surgical procedure. It is typically a polymer device designed for attachment to a handle and may in addition provide grip for improved manipulation of the handle; it is not designed to cover other equipment components. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	D832PS328T2	HIBCC	Case	20	In Commercial Distribution
Primary	D832PS328T1	HIBCC
Unit of Use	D832PS328T0	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K201604	000