PlastCare

Basic Information

• Brand Name: PlastCare
• Primary DI: D066PGNEEDLE27GL41
• Version / Model: PG-NEEDLE 27GL/4
• Catalog Number: PG-NEEDLE 27GL/4
• 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: 06820651-aefd-4096-b68c-af3c128b169e

Device Description

Anesthetic Dental Needles 27G/Long, 0.4mm x 30mm (Yellow)

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
DZM	Needle, Dental	Dental	872.4730	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63975	Dental anaesthesia syringe, single-use	A hand-held, manual dental instrument consisting of a barrel (cylinder) with plunger/piston intended to be used for injecting an anaesthetic agent, subcutaneously or intramuscularly, from a prefilled, single-use cartridge through an attached sterile needle (needle not included). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	D066PGNEEDLE27GL42	HIBCC		40	In Commercial Distribution
Primary	D066PGNEEDLE27GL41	HIBCC
Unit of Use	D066PGNEEDLE27GL40	HIBCC