Catalog Number

-

Brand Name

AHS

Version/Model Number

AHSGNSXL

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

FME

Product Code Name

Gown, Examination

Public Device Record Key

58d1e185-e607-447d-9b61-2b6d3a74327c

Public Version Date

April 07, 2021

Public Version Number

5

DI Record Publish Date

December 18, 2017

Package DI Number

B031AHSGNSXL1

Quantity per Package

50

Contains DI Package

B031AHSGNSXL0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box