InnoWave

Basic Information

• Brand Name: InnoWave
• Primary DI: 00724995152956
• Version / Model: IW1038
• Catalog Number: IW1038
• Company Name: MEDISAFE UK LIMITED
• Labeler DUNS: 505942961
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-02-21
• Public Version: 6
• Public Version Date: 2021-03-18
• Public Version Status: Update
• Public Device Record Key: 8d782e88-da24-4362-9680-a05674559b75
• Distribution End Date: 2021-03-18

Device Description

The InnoWave PCF XI Basket and Instrument Tubing is used with the The InnoWave PCF Sonic Irrigator.

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
Primary	00724995152956	GS1

Customer Contacts

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