Uni-Tip -Package of 25

Basic Information

• Brand Name: Uni-Tip -Package of 25
• Primary DI: 00014081016355
• Version / Model: B1635
• Company Name: HAGER WORLDWIDE, INC.
• Labeler DUNS: 009277971
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-03-08
• Public Version: 2
• Public Version Date: 2023-09-08
• Public Version Status: Update
• Public Device Record Key: 3b3bc367-544f-4467-8038-ec7786e37758
• Distribution End Date: 2023-08-01

Device Description

Chrome-plated air/water syringe

Device Characteristics

• Single Use: No
• 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: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ECB	UNIT, SYRINGE, AIR AND/OR WATER	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
65430	Dental delivery system irrigation handpiece tip	A rigid, tubular device intended to be fitted to the distal end of a dental delivery system irrigation handpiece (not included) to direct a stream of pressurized, warmed water and/or air to the field of operation in the oral cavity to irrigate/clear debris during a restorative or operative dental procedure. This is a single use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00014081016355	GS1

Customer Contacts

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