PlastCare

Basic Information

• Brand Name: PlastCare
• Primary DI: D066PGAWS031
• Version / Model: PG-AWS-03
• Catalog Number: PG-AWS-03
• Company Name: Proguard Health, Inc
• Labeler DUNS: 129529337
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 250
• Record Status: Published
• Publish Date: 2021-07-02
• Public Version: 1
• Public Version Date: 2021-07-12
• Public Version Status: New
• Public Device Record Key: bcbf46c7-12a0-4b29-b1fe-6c5cab280854

Device Description

Air Water Syringe Tips Clear

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: MR Safe
• 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
ECB	Unit, Syringe, Air And/Or Water	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
45131	Dental delivery system irrigation handpiece	A hand-held device that is used to regulate and direct a stream of pressurized, warmed water and/or air for the purpose of irrigating/clearing debris from the field of operation in the oral cavity during restorative or operative dental procedures. It is fitted with a long syringe-like nozzle that is activated by the user, typically through push-type controls. This device, also commonly known as a three-way or a Triplex syringe, is typically a component of a dental delivery system from which the air and water is supplied. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	D066PGAWS030	HIBCC
Primary	D066PGAWS031	HIBCC
Package	D066PGAWS032	HIBCC		48	In Commercial Distribution