Unipack

Basic Information

• Brand Name: Unipack
• Primary DI: D784URN552301
• Version / Model: URN-55230
• Catalog Number: URN-55230
• Company Name: UNIPACK MEDICAL CORPORATION
• Labeler DUNS: 018319397
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2022-12-06
• Public Version: 2
• Public Version Date: 2023-02-09
• Public Version Status: Update
• Public Device Record Key: 8865cb99-e9e2-44cd-8ab9-716e0b2dff83

Device Description

Irrigation Needle 30G Notched Luer Lock, Purple

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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
EIB	Syringe, irrigating (dental)	Dental	872.4565	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
Package	D784URN552305	HIBCC	Case	20	In Commercial Distribution
Primary	D784URN552301	HIBCC
Unit of Use	D784URN552300	HIBCC

Customer Contacts

• Phone: [phone] ext. 172
• Email: [email protected]