Catalog Number

-

Brand Name

AMG

Version/Model Number

ST001XXXL

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"

-

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

LYU

Product Code Name

Accessory, Surgical Apparel

Public Device Record Key

ea45cadc-f528-416b-9ee2-b3bba2db575d

Public Version Date

April 07, 2021

Public Version Number

2

DI Record Publish Date

July 23, 2020

Package DI Number

10850017650562

Quantity per Package

6

Contains DI Package

00850017650565

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case