Catalog Number

-

Brand Name

Cypress

Version/Model Number

34-120

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

-

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

341565b0-230d-46f8-9f09-b32611eec5d9

Public Version Date

July 14, 2020

Public Version Number

1

DI Record Publish Date

July 06, 2020

Package DI Number

00815555023691

Quantity per Package

3

Contains DI Package

00815555023684

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case