Unipack

Basic Information

• Brand Name: Unipack
• Primary DI: D784URN55103231
• Version / Model: URN-55103-23
• Catalog Number: URN-55103-23
• 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: 79598cdc-135c-44ce-9e49-329b2f15772d

Device Description

Combo Syringe 23G Side Port 3cc Luer Lock, Blue

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
35390	Irrigation syringe	A general-purpose device used primarily for the flushing of body orifices with an irrigating solution. It may be designed with (e.g., a rigid plastic barrel with a fitted rubber bulb at one end and a nozzle at the other). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	D784URN55103235	HIBCC	Case	20	In Commercial Distribution
Primary	D784URN55103231	HIBCC
Unit of Use	D784URN55103230	HIBCC

Customer Contacts

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