Catalog Number

E4-6200, 4-6200

Brand Name

AMT Stiffener for Initial Placement

Version/Model Number

E4-6200

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

47762b47-edea-44f6-8b23-34f4e586bafc

Public Version Date

November 23, 2021

Public Version Number

1

DI Record Publish Date

November 15, 2021

Package DI Number

00842071131173

Quantity per Package

10

Contains DI Package

00842071131166

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box (4-6200)