Catalog Number

-

Brand Name

Aegis Personal Protective Suit

Version/Model Number

005-00081

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)

-

Over the Counter (OTC)

Yes

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

6f9ffde5-8237-42b6-b8b0-481ce63029d5

Public Version Date

May 12, 2020

Public Version Number

1

DI Record Publish Date

May 04, 2020

Package DI Number

00872320005542

Quantity per Package

3

Contains DI Package

00872320005511

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Pack