Catalog Number

E4-6010, 4-6010

Brand Name

AMT Stiffener for Initial Placement

Version/Model Number

E4-6010

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

K042300,K042300

Product Code

KNT

Product Code Name

Tubes, Gastrointestinal (And Accessories)

Public Device Record Key

232b4737-c26b-4e14-ba3d-aff4433ba819

Public Version Date

November 10, 2021

Public Version Number

2

DI Record Publish Date

August 14, 2020

Package DI Number

00842071130626

Quantity per Package

10

Contains DI Package

00842071130619

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box (4-6010)