Niagara

Basic Information

• Brand Name: Niagara
• Primary DI: 05060247265278
• Version / Model: MP22062
• Catalog Number: IW1064
• Company Name: MEDISAFE UK LIMITED
• Labeler DUNS: 505942961
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-03-18
• Public Version: 1
• Public Version Date: 2021-03-26
• Public Version Status: New
• Public Device Record Key: d0e50e05-acd1-495b-b120-1510833912f3

Device Description

The Si Basket Tubing 10 is used with the IW PCF and or SI PCF S Sonic Irrigators.

Device Characteristics

• Single Use: No
• 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: No
• Has Manufacturing Date: Yes
• 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
MEC	Disinfector, medical devices	General Hospital	880.6992	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62151	Sterilizer/disinfector rack	A non-sterile rack or group of shelves intended to hold medical devices in a sterilizer or chemical washer/disinfector during the sterilization or washing/disinfection cycle. It may also be used to transport medical devices to and from the process and for their temporary storage. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	15060247265275	GS1	Case	10	In Commercial Distribution
Primary	05060247265278	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]