NA

Basic Information

• Brand Name: NA
• Primary DI: 05060247264660
• Version / Model: MED1018.1
• Catalog Number: IW1011
• 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: 5133cdaf-eb21-4f80-885a-db4a8c171dc9

Device Description

The Standard Basket and Tubing is used with IW Ultra and SI Digital 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
FLG	Cleaner, ultrasonic, medical instrument	General Hospital	880.6150	1

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
Primary	05060247264660	GS1

Customer Contacts

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