Catalog Number

AMM3675

Brand Name

Aero-Med

Version/Model Number

AMM3675

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

1ca0d6bb-7dde-4559-a952-2301c1768ded

Public Version Date

June 17, 2022

Public Version Number

3

DI Record Publish Date

March 27, 2020

Package DI Number

50810010892732

Quantity per Package

4

Contains DI Package

00810010892737

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE