PlastCare

Basic Information

• Brand Name: PlastCare
• Primary DI: D066PGFT211
• Version / Model: PG-FT21
• Catalog Number: PG-FT21
• Company Name: Proguard Health, Inc
• Labeler DUNS: 129529337
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• 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: 4732c5d3-5af6-4a1f-858e-c2f621d3fa97

Device Description

Pre-bent Flow Dispensing Tips 21G (Green)

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
EIB	Syringe, Irrigating (Dental)	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63696	Dental etching solution syringe	A hand-held, manual dental instrument consisting of a barrel (cylinder) with plunger intended to be used to dispense dental etching solution (etchant) to a patient’s tooth/teeth. It is intended to be filled once and used on multiple patients; disposable dispensing tips may be included. This device is reusable until the contents of the syringe are exhausted.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	D066PGFT210	HIBCC
Primary	D066PGFT211	HIBCC
Package	D066PGFT212	HIBCC		500	In Commercial Distribution