Catalog Number

-

Brand Name

Cypress

Version/Model Number

35-50

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

OEA

Product Code Name

Non-Surgical Isolation Gown

Public Device Record Key

5bcfe742-db36-4d53-a302-1492ca28d980

Public Version Date

April 07, 2021

Public Version Number

2

DI Record Publish Date

July 07, 2020

Package DI Number

20815555020274

Quantity per Package

150

Contains DI Package

10815555020277

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case