Catalog Number

OSA96X39LIT

Brand Name

Opt-Shield

Version/Model Number

OSA96X39LIT

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

Yes

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

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

-

Product Code

DWJ

Product Code Name

System, Thermal Regulating

Public Device Record Key

5d3cd028-4491-4860-b9a1-72f24a15f35c

Public Version Date

May 09, 2022

Public Version Number

5

DI Record Publish Date

August 11, 2017

Package DI Number

10868680000300

Quantity per Package

1

Contains DI Package

00868680000303

Package Discontinue Date

April 17, 2019

Package Status

Not in Commercial Distribution

Package Type

carton