Catalog Number

-

Brand Name

MT

Version/Model Number

FWB-10/55-6/23-S

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

KNQ

Product Code Name

Dilator, Esophageal

Public Device Record Key

2d4bca82-c8c1-435a-b6c7-11e7f4d265ac

Public Version Date

January 10, 2022

Public Version Number

1

DI Record Publish Date

December 31, 2021

Package DI Number

56932503524181

Quantity per Package

2

Contains DI Package

06932503524186

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box