Uni-Tip

Basic Information

• Brand Name: Uni-Tip
• Primary DI: D248B1629C1
• Version / Model: B1629C
• Company Name: HAGER WORLDWIDE, INC.
• Labeler DUNS: 009277971
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2024-05-20
• Public Version: 1
• Public Version Date: 2024-05-28
• Public Version Status: New
• Public Device Record Key: fdc96547-93c7-4e72-8d9e-72efd673252b

Device Description

Air/Water Syringe Tips

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: 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
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
Direct Marking	D248B16280	HIBCC
Primary	D248B1629C1	HIBCC