Irrigation Tray with 60cc Piston Syringe

Basic Information

• Brand Name: Irrigation Tray with 60cc Piston Syringe
• Primary DI: 00616784426822
• Version / Model: 4268
• Company Name: DYNAREX CORPORATION
• Labeler DUNS: 008124539
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-06-21
• Public Version: 1
• Public Version Date: 2021-06-29
• Public Version Status: New
• Public Device Record Key: f9578ea6-9267-4273-b9c2-c6c1c430197a

Device Description

Irrigation Tray with 60cc Piston Syringe: 800cc Outer Basin Tray, 500cc Plastic Graduate, Irrigation Piston Syringe, Protective Cap, Waterproof Drape, Antiseptic Wipe

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• 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
11371	Ear canal irrigation kit, single-use	A collection of items intended to be used to flush cerumen (ear wax) out of the ear canal during an ear/nose/throat (ENT) procedure. It consists of a manual syringe and other accessory items. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00616784426839	GS1	Case	20	In Commercial Distribution
Primary	00616784426822	GS1