Catalog Number

-

Brand Name

Gredale USA-Made AAMI Level 1 Isolation Gown (X-Large)

Version/Model Number

GRE1000-XL

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

afff8ebf-80a8-401c-9c2d-a7f0ed42aea2

Public Version Date

August 31, 2022

Public Version Number

1

DI Record Publish Date

August 23, 2022

Package DI Number

20860008925736

Quantity per Package

10

Contains DI Package

10860008925739

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE