Catalog Number

AEG-Straw

Brand Name

Ameritus

Version/Model Number

AEG-Straw

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

ILC

Product Code Name

Utensil, Eating

Public Device Record Key

f5bc886e-bd4e-4e16-adc1-7164b7faa23a

Public Version Date

April 08, 2022

Public Version Number

2

DI Record Publish Date

September 13, 2019

Package DI Number

30817522010605

Quantity per Package

800

Contains DI Package

10817522010601

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case