Catalog Number

MTT45L

Brand Name

Eye Shield

Version/Model Number

MTT45L

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K945515

Product Code

IWS

Product Code Name

Shield, eye, radiological

Public Device Record Key

1a67fa8f-832e-461e-bfaa-16057cc2c763

Public Version Date

July 17, 2020

Public Version Number

4

DI Record Publish Date

August 06, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-