Catalog Number

OSA90X39SUP

Brand Name

Opt-Shield Air Supine

Version/Model Number

OSA90X39SUP

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

29b36ce3-8d07-4008-a7fb-c3f7770c420f

Public Version Date

May 09, 2022

Public Version Number

3

DI Record Publish Date

June 29, 2018

Package DI Number

10868680000317

Quantity per Package

5

Contains DI Package

00868680000310

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box