Catalog Number

IW1011

Brand Name

NA

Version/Model Number

MED1018.1

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

5133cdaf-eb21-4f80-885a-db4a8c171dc9

Public Version Date

March 26, 2021

Public Version Number

1

DI Record Publish Date

March 18, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-