Catalog Number

-

Brand Name

Gredale USA-Made AAMI Level 2 Isolation Gown (X-Large)

Version/Model Number

GRE2000-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

37207be9-eec5-4fba-89d2-12a39980e153

Public Version Date

July 20, 2022

Public Version Number

1

DI Record Publish Date

July 12, 2022

Package DI Number

20860008925712

Quantity per Package

10

Contains DI Package

10860008925715

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case