GC PLASTIC SYRINGE

Basic Information

• Brand Name: GC PLASTIC SYRINGE
• Primary DI: D0470011751
• Version / Model: 001175
• Catalog Number: 001175
• Company Name: Gc America Inc.
• Labeler DUNS: 005473608
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-01-24
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: b568aaf2-ba1c-4947-aac6-896e9c34a3b6

Device Description

GC Plastic Syringe Kit, Packed with 2 syringes, extra "O" Rings, Tips and Cleaning Brush

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EID	SYRINGE, RESTORATIVE AND IMPRESSION MATERIAL	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35860	Dental impression material syringe, reusable	A non-sterile hand-held manual dental instrument designed to inject impression material into an impression tray or directly into a patient's mouth. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D0470011751	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]