Catalog Number

IWULTRAPL

Brand Name

InnoWave

Version/Model Number

IWULTRAPL

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

FLG

Product Code Name

Cleaner, ultrasonic, medical instrument

Public Device Record Key

4d940e04-4963-46a0-b7d4-0d061c390f35

Public Version Date

April 08, 2021

Public Version Number

1

DI Record Publish Date

March 31, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-