IRRIJET® Single-Use

Basic Information

• Brand Name: IRRIJET® Single-Use
• Primary DI: 60888937015944
• Version / Model: 55-2104
• Company Name: Coopersurgical, Inc.
• Labeler DUNS: 801895244
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-09-14
• Public Version: 4
• Public Version Date: 2024-02-28
• Public Version Status: Update
• Public Device Record Key: 219f726b-794e-43cd-93bb-2d22977f1cd3

Device Description

IRRIJET® Single-Use WOUND IRRIGATION SYSTEM • SPLATTER-GARD AND 12 CC SYRINGE

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: Yes
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	880.6960	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	30888937015943	GS1		4	In Commercial Distribution
Package	20888937015946	GS1		5	In Commercial Distribution
Primary	60888937015944	GS1