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InnoWave

FDA UDI

Class I (US FDA UDI)

by Medisafe Uk Limited

Identity

Trade Name
InnoWave FDA UDI
Generic Name
Ultrasonic-cleaning water bath FDA UDI
Device Name
The InnoWave Unity Ultrasonic Irrigator is a freestanding ultrasonic cleaner that gives you powerful performance with exceptional ease of use to meet the growing demands of your facility. FDA UDI
Model / Reference
Unity FDA UDI
Description
The InnoWave Unity Ultrasonic Irrigator is a freestanding ultrasonic cleaner that gives you powerful performance with exceptional ease of use to meet the growing demands of your facility. FDA UDI

Identifiers

Catalog Number
IW523046NPR FDA UDI
Primary DI / UDI-DI
00724995168698 FDA UDI
FDA Product Code
FLG FDA UDI
GMDN Term
Ultrasonic-cleaning water bath FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
880.6150 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Ultrasonic-cleaning water bath

InnoWave by Medisafe Uk Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ultrasonic-cleaning water bath.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medisafe Uk Limited

Sources (1)

  • FDA UDI 46783476-d061-4073-a767-6b57e13a373b 35 fields · synced May 30, 2026