Steri Irrigation Tip

Basic Information

• Brand Name: Steri Irrigation Tip
• Primary DI: 08806383562454
• Version / Model: SIDE OPEN TYPE 28G
• Catalog Number: 951-103
• Company Name: DiaDent Group International
• Labeler DUNS: 687789453
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-08-25
• Public Version: 1
• Public Version Date: 2020-09-02
• Public Version Status: New
• Public Device Record Key: 98f1b428-8950-4384-8c18-26a7036e0d55

Device Description

Steri Irrigation Tip Side Open Type designed as side-port and closed-end type is used for irrigating root canals and periodontal pockets.

Device Characteristics

• Single Use: Yes
• 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JEW	Tip, Rubber, Oral Hygiene	Dental	872.6650	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64403	Root canal irrigation blunt needle	A slender, hollow, tubular, metal instrument with a blunt tip designed specifically for irrigation of the root canal of a tooth during an endodontic procedure. Sometimes referred to as a root canal irrigation cannula, it is typically attached to a dental syringe (not included) filled with a root canal cleaning solution. It might be bent or straight and might have either a side vented tip or a blunt open-ended tip. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08806383562454	GS1