Catalog Number

AMM3675A

Brand Name

Aero-Med

Version/Model Number

AMM3675A

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

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

LRP

Product Code Name

TRAY, SURGICAL

Public Device Record Key

b46f3de5-e761-4884-88da-1b48cd25f11d

Public Version Date

June 17, 2022

Public Version Number

3

DI Record Publish Date

April 07, 2020

Package DI Number

50810010892763

Quantity per Package

4

Contains DI Package

00810010892768

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE