CanalPro Color Syringes

Basic Information

• Brand Name: CanalPro Color Syringes
• Primary DI: 16974843120168
• Version / Model: CanalPro Color Syringes (5 ml) yellow
• Company Name: ZOGEAR Medical Co., Ltd.
• Labeler DUNS: 710958353
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2023-04-20
• Public Version: 1
• Public Version Date: 2023-04-28
• Public Version Status: New
• Public Device Record Key: 9bb8fd65-9d96-4fc1-ad86-604bcdc2c277

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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
EIC	Syringe, Periodontic, Endodontic, Irrigating	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58894	Dental impression material syringe, single-use	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 single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	26974843120165	GS1	carton	24	In Commercial Distribution
Primary	16974843120168	GS1
Unit of Use	06974843120161	GS1