Catalog Number

-

Brand Name

AMG

Version/Model Number

1325

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

9bc5990b-a364-4cb1-a0e0-05810df2cfa7

Public Version Date

February 04, 2021

Public Version Number

1

DI Record Publish Date

January 27, 2021

Package DI Number

00810069260181

Quantity per Package

10

Contains DI Package

00810069260174

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case