Catalog Number

-

Brand Name

AHS

Version/Model Number

AHSSGXL

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

FYA

Product Code Name

Gown, Surgical

Public Device Record Key

b5c0ca9a-b779-4754-86b9-89e9296170da

Public Version Date

April 07, 2021

Public Version Number

5

DI Record Publish Date

December 18, 2017

Package DI Number

B031AHSSGXL1

Quantity per Package

35

Contains DI Package

B031AHSSGXL0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box